Trial · NCT00376675

Methylphenidate in Treating Patients With Fatigue Caused by Cancer

NCT00376675, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2014-10-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Methylphenidate in Treating Patients With Fatigue Caused by Cancer. Trials, record NCT00376675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00376675

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Methylphenidate in Treating Patients With Fatigue Caused by Cancer
NCT number: NCT00376675
Status: Completed
Phases: Phase 3
Enrollment: 148 participants, actual
Lead sponsor: Alliance for Clinical Trials in Oncology
Conditions: Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Interventions: methylphenidate hydrochloride, placebo
First posted: 2006-09-15
Last updated: 2016-08-01
Results first posted: 2014-10-10

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4	Baseline to week 4	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.
Secondary	Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	Baseline and Week 4	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.
Secondary	AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4	Baseline to Week 4	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.
Secondary	AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4	Baseline to Week 4	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.
Secondary	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	Baseline to Week 4	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.
Secondary	AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4	Baseline to Week 4	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.
Secondary	Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue	Baseline and Week 4	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).
Secondary	Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue	Baseline and Week 4	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).
Secondary	Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue	Baseline and Week 4	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).

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4	Baseline to week 4	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.	units on a scale	MEAN
SECONDARY	Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	Baseline and Week 4	All participants who have provided a baseline and week 4 SED scores were evaluable for this analysis.	units on a scale	MEAN
SECONDARY	AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4	Baseline to Week 4	All participants who have provided a baseline and one post-baseline PSQI score were evaluable for this analysis.	units on a scale * weeks	MEAN
SECONDARY	AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4	Baseline to Week 4	All participants who have provided a baseline and one post-baseline Vitality subscale score were evaluable for this analysis.	units on a scale * weeks	MEAN
SECONDARY	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	Baseline to Week 4	All participants who have provided a baseline and one post-baseline LASA score were evaluable for this analysis.	units on a scale * weeks	MEAN
SECONDARY	AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4	Baseline to Week 4	All participants who have provided a baseline and one post-baseline BFI score were evaluable for this analysis.	units on a scale * weeks	MEAN
SECONDARY	Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue	Baseline and Week 4	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.	units on a scale	MEAN
SECONDARY	Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue	Baseline and Week 4	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.	Units on scale	MEAN
SECONDARY	Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue	Baseline and Week 4	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.	Units on scale	MEAN

Source ClinicalTrials.gov

Results by group64

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4	Methylphenidate		50.33	Standard Deviation 20.32	units on a scale
Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4	Placebo		47.15	Standard Deviation 17.00	units on a scale
Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	Methylphenidate	Nervousness	-2.7	Standard Deviation 20.08	units on a scale
Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	Placebo	Nervousness	9.5	Standard Deviation 17.15	units on a scale
Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	Methylphenidate	Appetite decrease	-5.2	Standard Deviation 21.04	units on a scale
Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	Placebo	Appetite decrease	6.6	Standard Deviation 28.87	units on a scale
Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	Methylphenidate	Sex drive	-0.9	Standard Deviation 22.63	units on a scale
Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	Placebo	Sex drive	9.8	Standard Deviation 37.17	units on a scale
Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	Methylphenidate	Abdominal pain	-3.5	Standard Deviation 21.85	units on a scale
Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	Placebo	Abdominal pain	3.6	Standard Deviation 19.49	units on a scale

1 to 10 of 64Source ClinicalTrials.gov

See all 64 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Methylphenidate	69
Overall Study	STARTED	Placebo	70
Overall Study	COMPLETED	Methylphenidate	49
Overall Study	COMPLETED	Placebo	56
Overall Study	NOT COMPLETED	Methylphenidate	20
Overall Study	NOT COMPLETED	Placebo	14

Source ClinicalTrials.gov

Adverse events78

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hemoglobin decreased	Blood and lymphatic system disorders	Methylphenidate	0	68	0
other	Hemoglobin decreased	Blood and lymphatic system disorders	Placebo	1	69	1
other	Palpitations	Cardiac disorders	Methylphenidate	1	68	1
other	Palpitations	Cardiac disorders	Placebo	0	69	0
other	Abdominal pain	Gastrointestinal disorders	Methylphenidate	16	68	33
other	Abdominal pain	Gastrointestinal disorders	Placebo	21	69	53
other	Constipation	Gastrointestinal disorders	Methylphenidate	0	68	0
other	Constipation	Gastrointestinal disorders	Placebo	1	69	2
other	Diarrhea	Gastrointestinal disorders	Methylphenidate	1	68	1
other	Diarrhea	Gastrointestinal disorders	Placebo	0	69	0

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Methylphenidate
Total, all-cause mortality	Placebo
Total, other adverse events	Methylphenidate	56	68
Total, other adverse events	Placebo	54	69
Total, serious adverse events	Methylphenidate	0	68
Total, serious adverse events	Placebo	0	69

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20625123	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Methylphenidate vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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