A phase II, randomized, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue in prostate cancer patients receiving LHRH-agonist therapy - Abstract

OBJECTIVES: To investigate whether methylphenidate could alleviate fatigue, as measured by the Functional Assessment of Cancer Therapy: Fatigue subscale (FACT-F), in men with PCa treated with an LHRH agonist for a minimum of 6 months.

To assess changes in global fatigue and QoL as measured by the Bruera Global Fatigue Severity Scale (BFS) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), respectively.

MATERIALS AND METHODS: We performed a single center, randomized, double-blind, placebo-controlled trial with the goal to recruit 128 participants. Men treated with an LHRH agonist for PCa were screened between February 2008 and June 2012 for fatigue at our outpatient clinics using the BFS. Participants were randomized to receive either 10mg daily of methylphenidate or a placebo. Change of fatigue levels and in SF-36 scores between both groups were compared using linear regression adjusted for baseline scores.

RESULTS: The study was closed prematurely due to poor accrual. Of the 790 subjects screened, 24 men were randomized to methylphenidate or placebo (12 per group). After 10 weeks, the improvement in fatigue was greater in the methylphenidate arm than in placebo [+7.7(7.7) vs. +1.4(7.6)]; p=0.022). The within-group analysis demonstrated a significant improvement of fatigue in the methylphenidate arm (p=0.008) but not in the placebo arm (p=0.82). The use of methylphenidate also resulted in a significantly greater improvement in QoL as measured by the physical and mental component score than placebo (p=0.04 for both component scores).

CONCLUSION: Our findings support the benefit of methylphenidate on fatigue and QoL among men with LHRH-induced fatigue. Clinicians should be aware of its benefit and should consider discussing these findings with their fatigued patients.

Written by:
Richard PO, Fleshner NE, Bhatt JR, Hersey KM, Chahin R, Alibhai SM.   Are you the author?
Princess Margaret Cancer Centre, University of Toronto, Departments of Surgical Oncology/Urology, 610 University Ave, Room 3-130, Toronto, Ontario, Canada, M5G 2M9.

Reference: BJU Int. 2014 Mar 31. Epub ahead of print.
doi: 10.1111/bju.12755


PubMed Abstract
PMID: 24684534

UroToday.com Prostate Cancer Section