Fatigue Clinical Trial
Official title:
Long Acting Methylphenidate (Concerta™) for Cancer-Related Fatigue: A Phase III, Randomized, Double-Blind Placebo Controlled Study
RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known
whether methylphenidate is more effective than a placebo in relieving fatigue and improving
quality of life in patients with cancer.
PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it
works in treating patients with fatigue caused by cancer.
OBJECTIVES:
Primary
- Test the efficacy of long-acting methylphenidate in patients with cancer-related
fatigue as measured using an item of the Brief Fatigue Inventory.
Secondary
- Evaluate the tolerability and adverse events associated with this drug in these
patients.
- Study the effect of this drug on quality of life (QOL)-related variables (vitality,
sleep quality, overall QOL, QOL domains, other fatigue measures, and perceived
treatment efficacy) in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to disease stage (0, I, or II vs III or IV), level of fatigue at
baseline (4-7 vs 8-10), concurrent biological therapy (yes vs no), concurrent chemotherapy
(yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive oral methylphenidate daily on days 1-28.
- Arm II: Patients receive oral placebo daily on days 1-28.
Patients in both arms complete questionnaires to assess their symptoms of fatigue, overall
mood, quality of life, sleep quality, and adverse effects from treatment at baseline and
once weekly for 4 weeks. Patients also complete a Symptom Experience Diary.
McNeil Consumer & Specialty Pharmaceuticals provided medication support for NCCTG N05C7.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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