A Phase II, Randomized, Double-blind, Placebo Controlled Trial of Methylphenidate Hydrochloride for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH-Agonist Therapy
This study will determine if methylphenidate improves fatigue in men undergoing hormonal
therapy for prostate cancer. Fatigue is a common problem experienced by cancer patients.
Those patients who are receiving chemotherapy or radiation are especially vulnerable to
fatigue, as are men with prostate cancer who are receiving hormonal therapy with an
LHRH-agonist (androgen deprivation therapy). Eligible men will be randomized to a daily dose
of 10 mg methylphenidate or placebo for a total treatment period of 12 weeks. Subjects will
be monitored for changes in fatigue and mood during this period. While the exact cause of
fatigue in this setting is unknown, this study will hopefully lead to a better understanding
of the process and provide patients with a much-needed remedy for fatigue
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To assess the ability of methylphenidate 5 mg BID (10 mg daily) to reduce LHRH-agonist-related fatigue in prostate cancer patients as measured by the Functional Assessment of Cancer Therapy Fatigue subscale (FACT-F).
3 months pre-treatment (LHRH-agnost naive group only), randomization, 6 weeks, 10 weeks, 12 weeks, 24 weeks
Neil E Fleshner, MD
University Health Network, Toronto
Canada: Health Canada