The purpose of this study is to determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer with an LHRH-agonist.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.
Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.
UHN Princess Margaret Hospital
Toronto, Ontario, Canada
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).
Time frame: 3 months pre-treatment (LHRH-agnost naive group only), randomization, 6 weeks, 10 weeks, 12 weeks, 24 weeks
Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Bruera Global Fatigue Severity Scale
Time frame: Screening Visit 1, 3 months pre-treatment (LHRH-agonist naive group only), Screening Visit 2 (LHRH-agonist naive group only), Randomization, 2 weeks, 6 weeks, 10 weeks, 12 weeks, 24 weeks
Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Centre for Epidemiological Studies Depression Scale(CESD)
Time frame: Screening Visit 1, 3 months pre-treatment (LHRH-agonist naive group only), Screening Visit 2 (LHRH-agonist naive group only), Randomization, 6 weeks, 10 weeks, 24 weeks
Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Medical Outcomes Study 36-Item Short Form (SF-36)
Time frame: 3 months pre-treatment (LHRH-agonist naive group only), Randomization, 6 weeks, 10 weeks, 24 weeks
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