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Phase II, randomised, double‐blind, placebo‐controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH ‐agonist therapy
Author(s) -
Richard Patrick O.,
Fleshner Neil E.,
Bhatt Jaimin R.,
Hersey Karen M.,
Chahin Rehab,
Alibhai Shabbir M.H.
Publication year - 2015
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.12755
Subject(s) - placebo , methylphenidate , medicine , nottingham health profile , cancer related fatigue , quality of life (healthcare) , physical therapy , prostate cancer , cancer , attention deficit hyperactivity disorder , psychiatry , alternative medicine , nursing , pathology
Objectives To investigate whether methylphenidate can alleviate fatigue, as measured by the F unctional A ssessment of C ancer T herapy: Fatigue subscale, in men with prostate cancer ( PCa ) treated with a luteinizing hormone‐releasing hormone ( LHRH ) for a minimum of 6 months, and to assess changes in global fatigue and quality of life ( QoL ) as measured by the B ruera G lobal F atigue S everity S cale ( BFS ) and the M edical O utcomes S tudy 36‐ I tem S hort‐ F orm H ealth S urvey ( SF ‐36), respectively. Participants and Methods We performed a single‐centre, randomised, double‐blind, placebo‐controlled trial with the aim of recruiting 128 participants. Men treated with a LHRH agonist for PCa were screened between F ebruary 2008 and J une 2012 for fatigue at our outpatient clinics using the BFS . Participants were randomised to receive either 10 mg daily of methylphenidate or placebo. Change in 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 because of poor accrual. Of the 790 subjects screened, 24 men were randomised to methylphenidate or placebo (12 per group). After 10 weeks, the improvement in mean [ sd ] fatigue score was greater in the methylphenidate than in the placebo arm (+7.7 [7.7] vs +1.4 [7.6]; P = 0.022). The within‐group analysis showed a significant improvement in fatigue scores 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 summary scores than did the use of placebo ( P = 0.04 for both component scores). Conclusions Our findings support the beneficial effect of methylphenidate on fatigue and QoL among men with LHRH ‐induced fatigue. Clinicians should be aware of these benefits and should consider discussing these findings with patients who have high levels of fatigue.