Methylphenidate in Treating Patients With Fatigue Caused by Cancer

Phase 3 Completed 148 enrolled Alliance for Clinical Trials in Oncology McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · collab National Cancer Institute (NCI) · collab

RandomizedParallel-groupDouble-blindSupportive care

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.

Timeline

Start: 2008-02
Primary completion: 2010-06
Completion: 2010-06

Outcome

Missed primary endpoint

paper there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). PMID 20625123 ↗

Publications

Results Moraska AR, Sood A, Dakhil SR, Sloan JA, Barton D, Atherton PJ, Suh JJ, Griffin PC, Johnson DB, Ali A, Silberstein PT, Duane SF, Loprinzi CL. Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial. J Clin Oncol. 2010 Aug 10;28(23):3673-9. doi: 10.1200/JCO.2010.28.1444. Epub 2010 Jul 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	54 mg	Oral