Psychostimulants for Fatigue in Advanced Prostate Cancer
This study is open to men who have prostate cancer and report feeling fatigue. We will
examine the impact of psychostimulant treatment on depressive symptom severity,
neuropsychological test performance, and overall quality of life, as well as compare the
frequency and severity of treatment associated adverse side effects. We will be conducting a
six-week, randomized, double-blind, placebo-controlled, parallel design trial, evaluating
the relative benefits and risks of methylphenidate, (a psychostimulant medication).
Medication will be given in once or twice daily dosages (at 8 am and noon) and titrated by
one capsule every 2-3 days as needed to treat fatigue and as tolerated. Patients will be
examined regularly for safety. We will monitor vital signs and response to the medication.
This study will be the first of its kind to evaluate a pharmacologic intervention for
fatigue in cancer patients that utilizes a novel psychotropic agent (psychostimulant), and
assesses outcome with measures of fatigue, as well as side effects, psychological distress,
depression and overall quality of life.
Objectives: To study the efficacy of methylphenidate vs. placebo in the treatment of fatigue
in ambulatory men with prostate cancer.
To study the frequency and severity of adverse side effects associated with this
To study the effects of psychostimulant treatment for fatigue on related domains of
psychosocial function and quality of life.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
To study the efficacy of methylphenidate (Ritalin) versus placebo in the treatment of fatigue in ambulatory men with prostate cancer
Andrew Roth, M.D
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|