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Modafinil no different than placebo for fatigue reduction in NSCLC
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Modafinil and placebo were associated with improvements in cancer-associated fatigue in patients with advanced non–small-cell lung cancer, but researchers observed no significant differences between regimens, according to study results.
The central nervous system stimulant modafinil (Provigil, Cephalon) has limited evidence-based efficacy, yet it frequently is prescribed for the treatment of cancer-associated fatigue.
Anna Spathis, MSc, a consultant in palliative medicine at Addenbrookes Hospital in Cambridge, United Kingdom, and colleagues aimed to evaluate the safety and efficacy of modafinil for the management of fatigue in patients with NSCLC.
The study included 160 adults with advanced NSCLC, all of whom had a performance status of 0 to 2. None of the patients had undergone chemotherapy or radiotherapy within the previous 4 weeks.
Researchers randomly assigned patients to modafinil (100 mg daily on days 1 to 14, then 200 mg daily on days 15 to 28) or placebo.
Change in Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue score from baseline to 28 days served as the primary endpoint. Secondary endpoints included safety and patient-reported measures of depression, daytime sleepiness and quality of life.
FACIT-Fatigue scores improved from baseline to day 28 in both arms, but the difference in mean score changes — 5.29 (95% CI, 2.57-8.02) for modafinil and 5.09 (95% CI, 2.54-7.65) for placebo — was not statistically significant (mean score change, 0.2; 95% CI, 3.56-3.97).
Further, 47% of patients in the modafinil arm and 23% of patients in the placebo arm reported their assigned intervention was not helpful.
“We argue that the clinically significant placebo effect found in this trial is, in itself, an important finding,” Spathis and colleagues wrote. “Further research is needed to identify the precise component of being involved in a clinical trial and taking a placebo drug that improves this subjective symptom. Cancer-related fatigue is relatively neglected, beset by therapeutic nihilism on the part of both clinicians and patients. Simply allocating the time within a clinical consultation to acknowledge and discuss fatigue may benefit the many patients experiencing this distressing symptom.”
Disclosure:The researchers report no relevant financial disclosures.
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