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Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

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ClinicalTrials.gov Identifier: NCT01637077
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Academic and Community Cancer Research United

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Pain
Peripheral Neuropathy
Interventions Drug: pregabalin
Drug: placebo
Other: questionnaire administration
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Period Title: Overall Study
Started 23 23
Completed 19 22
Not Completed 4 1
Reason Not Completed
Cancel             1             1
Withdrawal by Subject             1             0
No cycle 1 questionnaire data             2             0
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo) Total
Hide Arm/Group Description Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. Total of all reporting groups
Overall Number of Baseline Participants 19 22 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 22 participants 41 participants
54.2  (12.9) 53.2  (14.3) 53.7  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 22 participants 41 participants
Female
19
 100.0%
22
 100.0%
41
 100.0%
Male
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 19 participants 22 participants 41 participants
19
 100.0%
22
 100.0%
41
 100.0%
1.Primary Outcome
Title Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score
Hide Description Worst of the pain scores for the week following the first cycle of paclitaxel administration, as measured by a question on the daily post-paclitaxel questionnaire. Worst pain over the first 6 days following treatment initiation. Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).
Time Frame From treatment initiation to 6 days following treatment initiation; up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.6  (2.5) 3.2  (3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Primary Outcome
Title Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1).
Hide Description Maximum of average pain scores over 6 days following initiation of treatment. Average pain over the first 6 days following treatment initiation. Maximum of the average pain scores (item 3, appendix IV; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") over the period from treatment initiation to day 7 (for cycle 1). Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).
Time Frame From treatment initiation to 6 days following treatment initiation; up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.6  (2.2) 2.2  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment.
Hide Description Average Area Under the Curve per assessment (aAUCpa) of worst, average, and least pain (items 1-3 app. IV; "Please rate any aches/pains that are NEW since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment by circling ONE number that best describes your aches/pains at its WORST in the last 24 hours.", "Please rate the same aches/pains by circling the ONE number that best describes your aches/pains at its LEAST in the last 24 hours.", "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the day-6 assessment.
Time Frame From treatment initiation to 6 days following treatment initiation; up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed for average pain over the past 24 hours differs from the overall number analyzed due to missing data.
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Mean (Standard Deviation)
Unit of Measure: average(subscale value*assessment)
Worst pain over the past 24 hours Number Analyzed 19 participants 22 participants
80.7  (22.3) 82.6  (24.0)
Average pain over the past 24 hours Number Analyzed 18 participants 22 participants
82.8  (20.2) 86.8  (19.7)
Least pain over the past 24 hours Number Analyzed 19 participants 22 participants
82.6  (23.0) 91.3  (14.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments Worst pain over the past 24 hours
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments Average pain over the past 24 hours
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments Least pain over the past 24 hours
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment
Hide Description The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
Time Frame Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Measure Type: Number
Unit of Measure: percentage of patients
2.2 0
5.Secondary Outcome
Title The Percentage of Patients Who Use Non-prescription Pain Medications
Hide Description The percentage of patients who use non-prescription pain medications are reported by arm below.
Time Frame From treatment initiation to 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Measure Type: Number
Unit of Measure: percentage of patients
52.6 50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title The Percentage of Patients Taking Opioid Medications
Hide Description The percentage of patients taking opioid medications are reported below by arm.
Time Frame From treatment initiation to 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Measure Type: Number
Unit of Measure: percentage of patients
15.8 18.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel
Hide Description The percentage of patients who report the development of new aches/pains that they attribute to paclitaxel in the first week of chemotherapy are reported by arm below.
Time Frame From treatment initiation to 6 days following treatment initiation; up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Measure Type: Number
Unit of Measure: percentage of patients
23.5 59.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V)
Hide Description The worst pain reported at the end of the week for the overall week ("New aches and pains at their worst over the past week") are reported below. This question was only supposed to be answered by patients who responded “yes” to the first question. Currently, all responses are included, regardless of whether the patient should’ve responded or not. The worst pain reported at the end of the week for the overall week (item 2 appendix V: "Please rate any aches/pains that you have by circling ONE number that best describes your aches/pains at its worst over the last week.") Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).
Time Frame From treatment initiation to 6 days following treatment initiation; up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.4  (2.1) 4.7  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
9.Secondary Outcome
Title The Percentage of Patients Who Report, at Week’s End, Using Non-prescription Pain Medications
Hide Description The percentage of patients who report, at week’s end, using non-prescription pain medications ("Have you used non-prescription meds like aspirin, Tylenol, Motrin, Ibuprofen, or Advil over the past week?") are reported by arm below. This question was only supposed to be answered by patients who responded “yes” to the first question. Currently, all responses are included, regardless of whether the patient should’ve responded or not.
Time Frame From treatment initiation to 6 days following treatment initiation; up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Measure Type: Number
Unit of Measure: percentage of patients
66.7 60.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Secondary Outcome
Title The Percentage of Patients Who Report, at Week’s End, Using Opioids
Hide Description The percentage of patients who report, at week’s end, using opioids ("Have you used opioids like codeine, oxycodone, or morphine for this pain over the past week?") are reported by arm below. This question was only supposed to be answered by patients who responded "yes" to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not.
Time Frame From treatment initiation to 6 days following treatment initiation; up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Measure Type: Number
Unit of Measure: percentage of patients
0 26.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
11.Secondary Outcome
Title Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales
Hide Description Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory, Autonomic, and Motor Neuropathy Subscales. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48), motor (items 37, 38, 41-45, 49), and autonomic (items 46, 47, 50) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the 6-month assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to 6-months are averaged to yield the aAUCpa per patient per subcale.
Time Frame From treatment initiation to 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Overall Number of Participants Analyzed 19 22
Mean (Standard Deviation)
Unit of Measure: average(subscale value*assessment)
Sensory 88.4  (12.5) 84.5  (16.7)
Autonomic 88.4  (17.6) 88.6  (15.8)
Motor 92.0  (11.0) 90.2  (10.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments Sensory neuropathy
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments Autonomic neuropathy
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I (Pregabalin), Arm II (Placebo)
Comments Motor neuropathy
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment
Adverse Event Reporting Description The revised NCI Common Terminology Criteria for AE (CTCAE) version 4.0 will be utilized for AE reporting. Cancels and Withdrawal by Subject in the Participant Flow table did not receive treatment. Serious AE (SAE) reports for this study may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited Adverse Events (EAEs), and appear in the SAE table.
 
Arm/Group Title Arm I (Pregabalin) Arm II (Placebo)
Hide Arm/Group Description Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
All-Cause Mortality
Arm I (Pregabalin) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/22 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Pregabalin) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      1/22 (4.55%)    
Gastrointestinal disorders     
Constipation  1  0/21 (0.00%)  0 1/22 (4.55%)  1
Metabolism and nutrition disorders     
Hyponatremia  1  1/21 (4.76%)  1 0/22 (0.00%)  0
Nervous system disorders     
Cognitive disturbance  1  1/21 (4.76%)  2 0/22 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Pregabalin) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/21 (71.43%)      21/22 (95.45%)    
Ear and labyrinth disorders     
Hearing impaired  1  2/21 (9.52%)  8 0/22 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  9/21 (42.86%)  54 14/22 (63.64%)  35
Diarrhea  1  1/21 (4.76%)  1 0/22 (0.00%)  0
General disorders     
Edema limbs  1  8/21 (38.10%)  34 13/22 (59.09%)  74
Fatigue  1  1/21 (4.76%)  2 2/22 (9.09%)  8
Pain  1  0/21 (0.00%)  0 1/22 (4.55%)  1
Investigations     
CD4 lymphocytes decreased  1  1/21 (4.76%)  1 0/22 (0.00%)  0
Lymphocyte count decreased  1  6/21 (28.57%)  13 3/22 (13.64%)  15
Neutrophil count decreased  1  0/21 (0.00%)  0 2/22 (9.09%)  2
Metabolism and nutrition disorders     
Hyponatremia  1  1/21 (4.76%)  1 0/22 (0.00%)  0
Nervous system disorders     
Cognitive disturbance  1  3/21 (14.29%)  10 3/22 (13.64%)  3
Dizziness  1  5/21 (23.81%)  27 6/22 (27.27%)  29
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  0/21 (0.00%)  0 1/22 (4.55%)  1
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  1/21 (4.76%)  1 0/22 (0.00%)  0
Vascular disorders     
Thromboembolic event  1  0/21 (0.00%)  0 2/22 (9.09%)  13
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Charles L. Loprinzi, M.D.
Organization: Mayo Clinic
Phone: 507/284-1623
EMail: loprinzi.charles@mayo.edu
Layout table for additonal information
Responsible Party: Academic and Community Cancer Research United
ClinicalTrials.gov Identifier: NCT01637077     History of Changes
Obsolete Identifiers: NCT02166385
Other Study ID Numbers: RC11C3
NCI-2011-03646 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: March 9, 2012
First Posted: July 10, 2012
Results First Submitted: January 8, 2018
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018