NCT00376675

Methylphenidate in Treating Patients With Fatigue Caused by Cancer

Long Acting Methylphenidate (Concerta™) for Cancer-Related Fatigue: A Phase III, Randomized, Double-Blind Placebo Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Fatigue
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	methylphenidate hydrochloride	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2006-09-15
• Last updated: 2016-08-01
• Results posted: 2014-10-10

Locations

238 sites across 1 country: United States