Positive effect of methylphenidate for cancer-related cognitive impairment: a pilot randomized trial.

Abstract

Breast cancer and its treatments can cause cancer-related cognitive impairment (CRCI). Methylphenidate (MPH) may help improve cognitive function. We evaluated the feasibility of using MPH to manage CRCI in women after breast cancer treatment in a pilot randomized, double-blind, placebo-controlled trial. Women who completed treatment for breast cancer ≥6 months prior and had documented cognitive dysfunction at trial entry were randomized to MPH or placebo (10 mg/day for 14 days, increased to 20 mg/day for an additional 14 days if tolerated). Patient-reported outcomes, including the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) and neuropsychological tests were administered on Days 0 (baseline), 15, and 29. Twenty women (mean age=50.2) were enrolled and randomized (MPH: n=9; placebo: n=11). All completed the study. Most had received chemotherapy (80%) in addition to surgery and radiotherapy and were taking hormonal therapy during study participation. Self-reported side effects were mild to moderate and transient. A linear mixed-effects model suggested greater improvement in FACT-Cog Perceived Cognitive Impairments scores in the MPH group compared to the placebo group on Day 29 (mean difference=10.1, p=0.02). No between-group differences were observed in neuropsychological test scores. MPH did not worsen physical, psychological, or sleep-related symptoms compared to placebo. This pilot study provides preliminary evidence that MPH may have clinically relevant effects on perceived cognitive dysfunction in women after breast cancer treatment and supports evaluation in a larger phase III trial.