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Methylphenidate in Treating Patients With Fatigue Caused by Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376675
Recruitment Status : Completed
First Posted : September 15, 2006
Results First Posted : October 10, 2014
Last Update Posted : August 1, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: methylphenidate hydrochloride
Other: placebo
Enrollment 148
Recruitment Details One-hundred and forty-eight (148) participants were recruited between February 2008 and August 2008 from 20 North Central Treatment Group (NCCTG) member sites.
Pre-assignment Details There were a total of 8 cancellations (5 Methylphenidate, 3 Placebo) and 1 ineligible participant on Placebo. These 9 participants were excluded from all analysis.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description Patients receive oral methylphenidate daily on days 1-28. Patients receive oral placebo daily on days 1-28.
Period Title: Overall Study
Started 69 70
Completed 49 56
Not Completed 20 14
Reason Not Completed
Withdrawal by Subject             9             2
Adverse Event             10             5
Other Reason             1             7
Arm/Group Title Methylphenidate Placebo Total
Hide Arm/Group Description Patients receive oral methylphenidate daily on days 1-28. Patients receive oral placebo daily on days 1-28. Total of all reporting groups
Overall Number of Baseline Participants 69 70 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 70 participants 139 participants
59.2  (11.23) 60.6  (13.82) 59.9  (12.58)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
<50 years 14 14 28
>=50 years 55 56 111
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Female
44
  63.8%
40
  57.1%
84
  60.4%
Male
25
  36.2%
30
  42.9%
55
  39.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   4.3%
5
   7.1%
8
   5.8%
White
66
  95.7%
64
  91.4%
130
  93.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.4%
1
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 69 participants 70 participants 139 participants
69 70 139
Current chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Yes 44 45 89
No 25 25 50
Curative intent treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Missing 0 2 2
Yes 34 30 64
No 35 38 73
Concurrent radiation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Yes 9 7 16
No 60 63 123
Concurrent biological therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Yes 17 17 34
No 52 53 105
Fatigue scale   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
4-7 47 48 95
8-10 22 22 44
[1]
Measure Description: Fatigue was measured using a scale of 0 to 10, with 0 (No fatigue) and 10 (Fatigue as bad as you can imagine).
Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
0/I/II 22 22 44
III/IV 47 48 95
[1]
Measure Description: Stage 0: Carcinoma in situ; Stage I, II and III: Higher numbers indicate more extensive disease: larger tumor size and/or spread of the cancer beyond the organ in which it first developed to nearby lymph nodes and/or tissues or organs adjacent to the location of the primary tumor; Stage IV: The cancer has spread to distant tissues or organs
Type of cancer  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Breast 26 20 46
Colon 4 4 8
Prostate 2 6 8
Lung 10 8 18
Combination/Unknown/Other 27 32 59
Average fatigue over the last week   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 69 participants 70 participants 139 participants
33.6  (15.43) 34.0  (17.23) 33.8  (16.30)
[1]
Measure Description: Fatigue was measured in a scale of 0 to 100 with 0 (poor quality of life or bad symptoms) and 100 (best quality of life or no symptoms).
Average pain over the last 24 hours   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 69 participants 70 participants 139 participants
87  (13.88) 86  (12.58) 86.3  (13.20)
[1]
Measure Description: Pain was measured in a scale of 0 to 100 with 0 (poor quality of life or bad symptoms) and 100 (best quality of life or no symptoms).
1.Primary Outcome
Title Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4
Hide Description

The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following:

  1. For those completed 4 weeks item: AUC/4;
  2. For those completed up to week 3 item: (AUC * 4) / 3;
  3. For those completed up to week 2 item: AUC * 2;
  4. For those completed up to week 1 item: AUC * 4;

The prorated AUC scores were then transformed onto 0 to 100 point scale with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms) for analysis.

Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants meeting the eligibility criteria who have signed a consent form, started treatment, and provided a baseline and one post-baseline usual fatigue score were evaluable for this analysis.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Patients receive oral methylphenidate daily on days 1-28.
Patients receive oral placebo daily on days 1-28.
Overall Number of Participants Analyzed 62 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
50.33  (20.32) 47.15  (17.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.317
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
2.Secondary Outcome
Title Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4
Hide Description The Symptom Experience Diary (SED) consists of 12 items. All scores were translated onto a 0-100 point scale, with 0 represent poor quality of life (QOL) or bad symptom and 100 is best QOL or no symptoms.The change in severity of adverse events was calculated as subtracting the item scores at baseline from the scores at week 4.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have provided a baseline and week 4 SED scores were evaluable for this analysis.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Patients receive oral methylphenidate daily on days 1-28.
Patients receive oral placebo daily on days 1-28.
Overall Number of Participants Analyzed 49 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
Nervousness -2.7  (20.08) 9.5  (17.15)
Appetite decrease -5.2  (21.04) 6.6  (28.87)
Sex drive -0.9  (22.63) 9.8  (37.17)
Abdominal pain -3.5  (21.85) 3.6  (19.49)
Dizziness -2.2  (15.58) 2.1  (17.76)
Shakiness -0.6  (11.97) 1.4  (18.82)
Heartbeat -2.0  (10.60) -1.6  (16.60)
Vomiting -0.8  (9.19) 0.4  (18.29)
Headaches -0.8  (18.80) 3.9  (17.34)
Trouble sleeping 10.6  (29.99) 11.1  (28.58)
Fatigue distress 22.9  (32.94) 15.8  (33.25)
Fatigue control satisfaction 28.0  (32.77) 23.2  (34.57)
3.Secondary Outcome
Title AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4
Hide Description Pittsburgh Sleep Quality Index (PSQI) consists of 19 items and 7 scales. The AUC for the overall PSQI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have provided a baseline and one post-baseline PSQI score were evaluable for this analysis.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Patients receive oral methylphenidate daily on days 1-28.
Patients receive oral placebo daily on days 1-28.
Overall Number of Participants Analyzed 63 65
Mean (Standard Deviation)
Unit of Measure: units on a scale * weeks
144.37  (110.32) 145.93  (108.21)
4.Secondary Outcome
Title AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4
Hide Description The SF-36 is a 36-item short form to measure health status in various populations. The vitality subscale is comprised of 4 items and is a measure of energy level as well as fatigue. The AUC for the vitality subscale at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have provided a baseline and one post-baseline Vitality subscale score were evaluable for this analysis.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Patients receive oral methylphenidate daily on days 1-28.
Patients receive oral placebo daily on days 1-28.
Overall Number of Participants Analyzed 69 68
Mean (Standard Deviation)
Unit of Measure: units on a scale * weeks
134.74  (88.77) 121.59  (76.31)
5.Secondary Outcome
Title AUC of Overall Quality of Life (QOL) and QOL Domains as Measured by the Linear Analogue Self Assessment at Baseline and at Weeks 1-4
Hide Description Linear Analogue Self Assessment (LASA) consists of 6 single-item numeric analogue scales. The AUC for the six-items at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have provided a baseline and one post-baseline LASA score were evaluable for this analysis.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Patients receive oral methylphenidate daily on days 1-28.
Patients receive oral placebo daily on days 1-28.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: units on a scale * weeks
Overall QOL 204.21  (103.16) 201.34  (94.65)
Mental well-being 227.04  (109.61) 226.40  (100.62)
Physical well-being 188.13  (98.12) 191.07  (87.23)
Emotional well-being 203.65  (105.32) 215.65  (96.90)
Social activity 189.68  (112.89) 177.34  (95.99)
Spiritual well-being 231.24  (122.30) 255.88  (113.74)
6.Secondary Outcome
Title AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4
Hide Description Area under the curve (AUC) for the other fatigue items of the BFI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have provided a baseline and one post-baseline BFI score were evaluable for this analysis.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Patients receive oral methylphenidate daily on days 1-28.
Patients receive oral placebo daily on days 1-28.
Overall Number of Participants Analyzed 68 69
Mean (Standard Deviation)
Unit of Measure: units on a scale * weeks
Fatigue right now 179.96  (100.06) 174.94  (92.95)
Worst fatigue last 24 hours 144.59  (92.95) 126.36  (82.13)
Fatigue interference with general activity 187.60  (106.88) 171.06  (98.11)
Fatigue interference with mood 205.31  (106.89) 220.29  (114.85)
Fatigue interference with walking ability 210.09  (125.36) 206.46  (120.76)
Fatigue interference with normal work 179.94  (106.40) 168.84  (104.20)
Fatigue interference with relations with others 224.72  (114.46) 243.87  (115.95)
Fatigue interference with enjoyment of life 194.15  (115.11) 184.12  (111.10)
7.Secondary Outcome
Title Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue
Hide Description Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of "a little better" via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of "a little better" via SGIC scores.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Patients receive oral methylphenidate daily on days 1-28.
Patients receive oral placebo daily on days 1-28.
Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.9  (18.1) 15  (22.2)
8.Secondary Outcome
Title Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue
Hide Description Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of "a little better" via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of "a little better" via SGIC scores.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Patients receive oral methylphenidate daily on days 1-28.
Patients receive oral placebo daily on days 1-28.
Overall Number of Participants Analyzed 13 7
Mean (Standard Deviation)
Unit of Measure: Units on scale
20.0  (14.7) 11.4  (27.3)
9.Secondary Outcome
Title Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue
Hide Description Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of "a little better" via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of "a little better" via SGIC scores.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Patients receive oral methylphenidate daily on days 1-28.
Patients receive oral placebo daily on days 1-28.
Overall Number of Participants Analyzed 10 13
Mean (Standard Deviation)
Unit of Measure: Units on scale
31.0  (24.7) 23.8  (29.3)
Time Frame 4 weeks
Adverse Event Reporting Description One participant on Methylphenidate and one participant on placebo did not have adverse event data provided post baseline.
 
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description Patients receive oral methylphenidate daily on days 1-28. Patients receive oral placebo daily on days 1-28.
All-Cause Mortality
Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Methylphenidate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/68 (0.00%)      0/69 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Methylphenidate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/68 (82.35%)      54/69 (78.26%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Cardiac disorders     
Palpitations  1  1/68 (1.47%)  1 0/69 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  16/68 (23.53%)  33 21/69 (30.43%)  53
Constipation  1  0/68 (0.00%)  0 1/69 (1.45%)  2
Diarrhea  1  1/68 (1.47%)  1 0/69 (0.00%)  0
Flatulence  1  1/68 (1.47%)  2 0/69 (0.00%)  0
Nausea  1  1/68 (1.47%)  1 0/69 (0.00%)  0
Vomiting  1  0/68 (0.00%)  0 1/69 (1.45%)  2
General disorders     
Disease progression  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Fatigue  1  2/68 (2.94%)  5 4/69 (5.80%)  9
Fever  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Infections and infestations     
Infection  1  0/68 (0.00%)  0 1/69 (1.45%)  3
Injury, poisoning and procedural complications     
Bruising  1  1/68 (1.47%)  1 0/69 (0.00%)  0
Fracture  1  1/68 (1.47%)  1 0/69 (0.00%)  0
Investigations     
Leukocyte count decreased  1  2/68 (2.94%)  2 0/69 (0.00%)  0
Lymphocyte count decreased  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Neutrophil count decreased  1  1/68 (1.47%)  1 0/69 (0.00%)  0
Platelet count decreased  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Metabolism and nutrition disorders     
Anorexia  1  2/68 (2.94%)  2 1/69 (1.45%)  1
Blood glucose increased  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Serum albumin decreased  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Serum potassium decreased  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Serum sodium decreased  1  0/68 (0.00%)  0 2/69 (2.90%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  0/68 (0.00%)  0 2/69 (2.90%)  4
Nervous system disorders     
Dizziness  1  18/68 (26.47%)  40 25/69 (36.23%)  58
Headache  1  28/68 (41.18%)  55 21/69 (30.43%)  39
Intracranial hemorrhage  1  1/68 (1.47%)  1 0/69 (0.00%)  0
Peripheral sensory neuropathy  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Syncope  1  1/68 (1.47%)  1 1/69 (1.45%)  1
Tremor  1  1/68 (1.47%)  1 1/69 (1.45%)  1
Psychiatric disorders     
Anxiety  1  24/68 (35.29%)  44 24/69 (34.78%)  66
Confusion  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Depression  1  1/68 (1.47%)  1 1/69 (1.45%)  1
Insomnia  1  37/68 (54.41%)  80 32/69 (46.38%)  80
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  0/68 (0.00%)  0 1/69 (1.45%)  4
Rash desquamating  1  1/68 (1.47%)  1 0/69 (0.00%)  0
Sweating  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Vascular disorders     
Hypotension  1  0/68 (0.00%)  0 1/69 (1.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amit Sood
Organization: Mayo Clinic
Phone: 507-284-1623
EMail: sood.amit@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00376675    
Other Study ID Numbers: NCCTG-N05C7
NCI-2012-02701 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000495148 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: September 13, 2006
First Posted: September 15, 2006
Results First Submitted: July 30, 2014
Results First Posted: October 10, 2014
Last Update Posted: August 1, 2016