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.

Patients with a histologically or cytologically confirmed cancer, except for any of the following: Brain cancer, including primary CNS malignancy or brain metastases CNS lymphoma Patients must have history of cancer-related fatigue for ? 1 month Contact Coordinator for additional eligibility information

Study Summary:

Detailed Study Description:

Study Design: Interventional, Blinded
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Cancer-related fatigue
Intervention Type: Drug
Intervention Name: Methylphenidate (Concerta™)
Gender: Male and Female
Age group: Interventional
Sponsor: North Central Cancer Treatment Group