AMELIA ISLAND, Florida—Methylphenidate (Ritalin) effectively reduces fatigue in men with prostate cancer; however, careful monitoring is essential because the psychostimulant can also elevate blood pressure and pulse rates, according to a trial presented at the American Psychosocial Oncology Society (APOS) Third Annual Conference (abstract P16-3). "Blood pressure elevations were the largest factor in men not tolerating this medicine," said Andrew J. Roth, PhD, of Memorial Sloan-Kettering Cancer Center.

The National Institutes of Health (NIH)-funded trial, which is ongoing, is a 6-week, randomized, double-blind, placebo-controlled parallel-design study evaluating the relative benefits and risks of methylphenidate in alleviating fatigue in ambulatory prostate cancer patients. At the time of the study, the investigators had enrolled 35 men out of the 91 who met their initial fatigue criteria.

The methylphenidate group reported a reduction in their fatigue levels from baseline (P < .05) as measured by the Brief Fatigue Inventory (BFI) scale and fatigue severity subscale, which asked the men to rate their current fatigue, their fatigue at its worst in the past 24 hours, and their fatigue on average. In addition, 73% of the methylphenidate group reported a significant reduction in fatigue, compared with 23% of the placebo group.

However, 35% of the men randomized to methylphenidate dropped out of the study due to cardiovascular side effects, in particular, elevated blood pressure. "Methylphenidate can be effective in reducing fatigue," Dr. Roth commented, "but oncologists need to monitor these men carefully for possible pulse and blood pressure elevations."

He added that their experience confirms the difficulty other researchers have had in recruiting older patients to clinical oncology trials. "It appears that older men with prostate cancer are not interested in taking a medication for fatigue," he said. "A number of our patients who had significant fatigue did not want to participate in another clinical trial. Also, a number of patients were excluded because they had a medical or psychiatric condition that precluded their eligibility for the trial."

Originally, the study plan called for patients to return to the hospital weekly for 6 weeks for vital sign checks, but this was burdensome for many of the men, Dr. Roth said. "We found that we could monitor the vital signs accurately with home monitoring, which increased accrual somewhat."