A placebo-controlled trial did not show a significant fatigue benefit from dexamphetamine in patients with stable primary brain tumors. A stimulant’s alerting reputation did not establish effectiveness for this clinically distinct form of fatigue.
Laigle-Donadey and colleagues conducted a double-blind multicenter trial of dexamphetamine sulfate, up to 30 mg daily, over three months. Participants had severe fatigue and stable disease. Forty-six received treatment and 41 were evaluable for analysis, including 22 in the dexamphetamine group and 19 in the placebo group. Fatigue was the primary outcome; mood, cognition and quality of life were also examined.
At three months, the investigators found no statistically significant treatment differences in the reported fatigue, cognitive, mood or quality-of-life outcomes. Psychiatric adverse effects, including hyperactivity, anxiety, sleep disturbance and irritability, were more frequent with dexamphetamine (p = 0.018). Tolerability and efficacy answer different questions: the absence of treatment-related deaths or grade-four toxicity did not demonstrate useful symptom relief.
The sample was small and included different tumor types and treatment histories. The null finding does not prove that every patient would have an identical response, but it does mean the trial failed to establish benefit under its conditions. Effects in ADHD, healthy volunteers or sleep deprivation cannot simply be substituted for this population. Fatigue ratings are also not measures of drug concentration or driving ability. The study provides direct evidence against assuming a general stimulant effect translates into relief of cancer-related fatigue, while highlighting adverse effects that remain relevant even when efficacy is unproven.
See stimulant effects during experimentally imposed sleep deprivation.