Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy.

What Was Tested

This randomized controlled trial looks at Methylphenidate.

To investigate whether methylphenidate can alleviate fatigue, as measured by the Functional Assessment of Cancer Therapy: 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 Bruera Global Fatigue Severity Scale (BFS) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), respectively.

The researchers performed a single-centre, randomised, double-blind, placebo-controlled trial with the aim of recruiting 128 participants.

Who Took Part

The abstract describes 128 participants taking part.

PubMed tags the participants as men only.

Men treated with a LHRH agonist for PCa were screened between February 2008 and June 2012 for fatigue at their outpatient clinics using the BFS.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

The participants were allocated by chance, so the Methylphenidate group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Methylphenidate, so expectations could not easily colour the readings.

Some participants received a placebo instead of Methylphenidate, giving a reference point.

Change in fatigue levels and in SF-36 scores between both groups were compared using linear regression, adjusted for baseline scores.

What Was Measured

Topics PubMed links to this paper include Androgen Antagonists, Central Nervous System Stimulants, Fatigue, Methylphenidate, Prostatic Neoplasms, Quality of Life and Receptors, LHRH.

Author keywords: androgen deprivation therapy, gonadotropin-releasing hormone and prostate cancer.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Methylphenidate in 128 participants.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2015 (BJU international), a journal based in England.

More context: all human trials.