Patients with advanced non-small-cell lung cancer (NSCLC) who received the central nervous system (CNS) stimulant modafinil reported no greater reduction in fatigue than patients given placebo, show study results.
All patients in the cohort experienced clinically important improvement in fatigue after 1 month of treatment, as measured on the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue subscale, but there was no significant difference between the two study arms.
“It could be the consequence of a placebo effect from receiving an intervention or another aspect of taking part in a clinical trial; it may represent the natural history of the symptom over time; or it could be an artifact related to recruiting only a subgroup of patients with fatigue above a certain level”, suggests the research team in the Journal of Clinical Oncology.
The double blind, placebo-controlled, randomised clinical trial took place at 24 hospitals in the UK and enrolled 208 patients with NSCLC and a World Health Organization performance status of 0 to 2. Half of the cohort was randomly assigned to receive modafinil 100 mg and half to a matched placebo capsule. Patients took one capsule of modafinil or placebo daily for 14 days, followed by two capsules daily for a further 14 days.
Anna Spathis (Addenbrookes Hospital, Cambridge, UK) and colleagues report that mean FACIT–Fatigue scores improved through the study, at an increase of 5.29 points between baseline and 28 days for patients who received modafinil, and 5.09 for those who received placebo. An increase of three points or more is considered clinically meaningful, the researchers explain.
However, there was no statistically significant difference in FACIT–Fatigue score according to treatment, they add, even after adjusting data for disease stage and patient age.
A similar rate of adverse events was reported by the modafinil and placebo group, at a respective 55.8% and 54.4%, with most serious adverse events considered to be unrelated to the study treatment and to be expected in this patient group, note Spathis et al.
Previous studies involving modafinil for the management of cancer-related fatigue have resulted in National Comprehensive Cancer Network guidelines recommending its use for patients with cancer “during active treatment, after treatment, and at the end of life”, remark the researchers. They add that their current findings provide “important negative evidence” for this recommendation.
“Simply allocating the time within a clinical consultation to acknowledge and discuss fatigue may benefit the many patients experiencing this distressing symptom”, concludes the team.
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