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Trial of Pregabalin for Granulocyte Colony-stimulating Factor (GCSF)-Induced Bone Pain

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ClinicalTrials.gov Identifier: NCT03407430
Recruitment Status : Terminated (Low patient accrual)
First Posted : January 23, 2018
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Breast Cancer
Lymphoma
Pain
Interventions Drug: Pregabalin
Drug: Placebo
Enrollment 11
Recruitment Details Subjects were recruited from 11/2015 through 07/2017.
Pre-assignment Details Eleven subjects were screened and successfully consented to this trial. Of these, three subjects either had therapy alteration that led to their exclusion or left without study-related medication, thus 8 subjects were treated.
Arm/Group Title Pregabalin, Then Placebo Placebo, Then Pregabalin
Hide Arm/Group Description

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Period Title: First Intervention
Started 5 3
Completed 5 3
Not Completed 0 0
Period Title: Washout
Started 5 3
Completed 4 3
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Period Title: Second Intervention
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title Pregabalin, Then Placebo Placebo, Then Pregabalin Total
Hide Arm/Group Description

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Total of all reporting groups
Overall Number of Baseline Participants 5 3 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  80.0%
3
 100.0%
7
  87.5%
>=65 years
1
  20.0%
0
   0.0%
1
  12.5%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 3 participants 8 participants
46.2
(23 to 71)
51.3
(33 to 62)
48.1
(23 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 8 participants
Female
4
  80.0%
2
  66.7%
6
  75.0%
Male
1
  20.0%
1
  33.3%
2
  25.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 8 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  33.3%
1
  12.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  20.0%
0
   0.0%
1
  12.5%
White
4
  80.0%
2
  66.7%
6
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants 3 participants 8 participants
5
 100.0%
3
 100.0%
8
 100.0%
Serum creatinine (SCr)  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 5 participants 3 participants 8 participants
0.7
(0.5 to 0.9)
0.6
(0.6 to 0.7)
0.7
(0.5 to 0.9)
Baseline pain score   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 5 participants 3 participants 8 participants
0.8
(0 to 2)
3.3
(2 to 6)
1.8
(0 to 6)
[1]
Measure Description: The ten-point numerical scale is scored as an integer from 0 to 10. Participants will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.” As such, higher values (approaching 10) signify worse outcomes.
Body Mass Index (BMI)  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 5 participants 3 participants 8 participants
28.2
(20.1 to 32.0)
24.3
(20.6 to 26.8)
26.7
(20.1 to 32.0)
Body Surface Area (BSA)  
Mean (Full Range)
Unit of measure:  M^2
Number Analyzed 5 participants 3 participants 8 participants
1.89
(1.68 to 2.16)
1.86
(1.82 to 1.91)
1.88
(1.68 to 2.16)
Eastern Cooperative Oncology Group (ECOG) performance status   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 5 participants 3 participants 8 participants
0.4
(0 to 1)
0.3
(0 to 1)
0.4
(0 to 1)
[1]
Measure Description:

Measure Description: A scale from 0-5 to describe a patient's level of functioning in terms of selfcare ability and activity level.

0, Fully active

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
  3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
  4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
  5. Dead
Baseline neuropathic pain scale   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 5 participants 3 participants 8 participants
0
(0 to 0)
0.3
(0 to 1)
0.1
(0 to 1)
[1]
Measure Description:

The ID-Pain scale (i.e. neuropathic pain scale) is a 6-item, participant-completed screening tool to help differentiate nociceptive and neuropathic pain.

  1. Did the pain feel like pins and needles?
  2. Did the pain feel hot/burning?
  3. Did the pain feel numb?
  4. Did the pain feel like electrical shocks?
  5. Is the pain made worse with the touch of clothing or bed sheets?
  6. Is the pain limited to your joints?

A “yes” response to questions 1–5 are scored as 1; for question 6, is scored as −1. As such, higher scores (approaching 5) signify worse outcomes. Scale total range of -1 to 5.

1.Primary Outcome
Title Number of Patients Who Have an Increase in Pain Score of ≥ 3 From Baseline Through the End of Study Medication in Cycle 1
Hide Description

Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B.

The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.”

Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Intervention = Pregabalin First Intervention = Placebo
Hide Arm/Group Description:

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg twice a day (BID) for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Overall Number of Participants Analyzed 5 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Proportion of Patients Who Have an Increase in Pain Score of ≥ 3 From Baseline Between Pregabalin and Placebo Across the 2 Cycles
Hide Description

Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline between pregabalin and placebo across the 2 cycles.

The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.”

Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Intervention = Pregabalin Second Intervention = Placebo First Intervention = Placebo Second Intervention = Pregabalin
Hide Arm/Group Description:

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Overall Number of Participants Analyzed 5 4 3 3
Measure Type: Number
Unit of Measure: proportion
0 0.5 0 0.333
3.Secondary Outcome
Title Proportion of Patients Who Have an Increase in Bone/Joint Pain Score of ≥ 3 From Baseline Through the End of Study Medication in Cycle 1
Hide Description

Compare the proportion of patients who have an increase in bone/joint pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B.

The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.”

Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Intervention = Pregabalin First Intervention = Placebo
Hide Arm/Group Description:

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Overall Number of Participants Analyzed 5 3
Measure Type: Number
Unit of Measure: proportion
0 0
4.Secondary Outcome
Title Number of Days of Breakthrough Analgesic Use Between Pregabalin and Placebo Across the 2 Cycles
Hide Description

Compare the number of days of breakthrough analgesic use between pregabalin and placebo within cycle 1 and across the 2 cycles.

The number of days of breakthrough analgesic use (i.e additional pain medication being required) is evaluated based on participant-provided medication logs kept during study treatment. If additional pain medication outside of their normal pain control regimen was reported, this day counts as 1. The total days for each patient are then reported, with a total range from zero to 14 (for patients with breast cancer) or zero to 21 (for patients with a lymphoma).

Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Intervention = Pregabalin Second Intervention = Placebo First Intervention = Placebo Second Intervention = Pregabalin
Hide Arm/Group Description:

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Overall Number of Participants Analyzed 5 4 3 3
Mean (Full Range)
Unit of Measure: days
1.4
(0 to 5)
3.25
(0 to 13)
0.67
(0 to 1)
0
(0 to 0)
5.Secondary Outcome
Title Proportion of Patients With Severe Pain Between Pregabalin and Placebo Across the 2 Cycles
Hide Description

Compare the proportion of patients with severe pain between pregabalin and placebo within cycle 1 and across the 2 cycles.

The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.”

Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Intervention = Pregabalin Second Intervention = Placebo First Intervention = Placebo Second Intervention = Pregabalin
Hide Arm/Group Description:

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Overall Number of Participants Analyzed 5 4 3 3
Measure Type: Number
Unit of Measure: proportion
0.4 0.25 0.67 0
6.Secondary Outcome
Title Maximum Change in Pain Score From Baseline Between Pregabalin and Placebo Across the 2 Cycles
Hide Description

Compare the maximum change in pain score from baseline between pregabalin and placebo within cycle 1 and across the 2 cycles.

The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.” Each patient will be assessed regularly, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).

Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Intervention = Pregabalin Second Intervention = Placebo First Intervention = Placebo Second Intervention = Pregabalin
Hide Arm/Group Description:

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Overall Number of Participants Analyzed 5 4 3 3
Mean (Full Range)
Unit of Measure: units on a scale
0.4
(0 to 2)
2
(0 to 4)
0
(0 to 0)
1.67
(0 to 5)
7.Secondary Outcome
Title Maximum Neuropathic Pain Score Between Pregabalin and Placebo Across the 2 Cycles
Hide Description

Compare the maximum neuropathic pain score between pregabalin and placebo within cycle 1 and across the 2 cycles.

The "ID Pain" scale (also know as the "Identify Pain" scale) is a 6-item, participant-completed screening tool designed to help differentiate nociceptive and neuropathic pain. This pain score also helps to evaluate the presence/absence of neuropathic pain at a given point of time.

  1. Did the pain feel like pins and needles?
  2. Did the pain feel hot/burning?
  3. Did the pain feel numb?
  4. Did the pain feel like electrical shocks?
  5. Is the pain made worse with the touch of clothing or bed sheets?
  6. Is the pain limited to your joints?

A "yes" response to questions 1-5 are scored as 1; for question 6, a "yes" is scored as −1. As such, higher scores (approaching 5) signify worse outcomes. The scale's total range for a patient is -1 to 5.

Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Intervention = Pregabalin Second Intervention = Placebo First Intervention = Placebo Second Intervention = Pregabalin
Hide Arm/Group Description:

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Overall Number of Participants Analyzed 5 4 3 3
Mean (Full Range)
Unit of Measure: units on a scale
0.2
(0 to 1)
0.5
(0 to 2)
0
(0 to 0)
0.33
(0 to 1)
8.Secondary Outcome
Title Number of Subjects That Experienced a Grade 2 or Higher Adverse Events When Taking Pregabalin
Hide Description CTCAE The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Intervention = Pregabalin Second Intervention = Pregabalin
Hide Arm/Group Description:

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Overall Number of Participants Analyzed 5 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame During the first two cycles of therapy (roughly 12 weeks from initiation of therapy), or during a total of 24 weeks. Each patient will be assessed regularly for the development of any toxicity, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title First Intervention = Pregabalin Second Intervention = Placebo First Intervention = Placebo Second Intervention = Pregabalin
Hide Arm/Group Description

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Pregabalin in cycle 1; placebo in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

Placebo in cycle 1; pregabalin in cycle 2.

Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.

Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.

All-Cause Mortality
First Intervention = Pregabalin Second Intervention = Placebo First Intervention = Placebo Second Intervention = Pregabalin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/4 (0.00%)      0/3 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
First Intervention = Pregabalin Second Intervention = Placebo First Intervention = Placebo Second Intervention = Pregabalin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/4 (0.00%)      0/3 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
First Intervention = Pregabalin Second Intervention = Placebo First Intervention = Placebo Second Intervention = Pregabalin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      4/4 (100.00%)      3/3 (100.00%)      3/3 (100.00%)    
Gastrointestinal disorders         
Nausea * 1  3/5 (60.00%)  3 1/4 (25.00%)  1 2/3 (66.67%)  2 0/3 (0.00%)  0
Stomach pain * 1  2/5 (40.00%)  2 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Constipation * 1  0/5 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0
Diarrhea * 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
General disorders         
Fatigue * 1  3/5 (60.00%)  3 2/4 (50.00%)  2 3/3 (100.00%)  3 3/3 (100.00%)  3
Pain * 1  1/5 (20.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders         
Back pain * 1  0/5 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1
Bone pain * 1  1/5 (20.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders         
Dizziness * 1  4/5 (80.00%)  4 0/4 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1
Drowsiness/Somnolence * 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Headache * 1  1/5 (20.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
Reproductive system and breast disorders         
Pelvic pain * 1  1/5 (20.00%)  1 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
We were unable to achieve the target number of subject participants (target n=60; accrual n=11) needed to achieve target power and statistically reliable results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Benyam Muluneh
Organization: University of North Carolina Medical Center
Phone: 919-966-3213
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03407430     History of Changes
Other Study ID Numbers: LCCC 1314
First Submitted: January 2, 2018
First Posted: January 23, 2018
Results First Submitted: April 6, 2018
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018