A Pilot Study Evaluating the Safety and Efﬁcacy of Modaﬁnal for Cancer-Related Fatigue
- September 22, 2014
- Support Groups
Abstract: Fatigue is a common symptom that lowers the quality of life of patients with cancer, affecting between 60% and 90% of patients. Relatively few options are available for the treatment of this debilitating condition. Modaﬁnal, a psychostimulant developed for the treatment of narcolepsy, has been used to treat fatigue in other diseases such as multiple sclerosis, but little data support its use in cancer patients.
Objective and design: The primary objective of this open-label pilot study was to evaluate the safety, and efﬁcacy of modaﬁnil in improving cancer-related fatigue (CRF) as measured by the Brief Fatigue Inventory (BFI). The effect of this agent on depression, quality of life, functional status, and cognitive function was also assessed. Modaﬁnal was self-administered at a dose of 100 mg=d during weeks 1–2, and 200 mg during weeks 3–4. Assessments were performed at baseline, 2, and 4 weeks.
Results: BFI score was improved in 46% of patients at 2 weeks and 75% at 4 weeks (p=0.025). Hospital Anxiety and Depression Scale scores declined at 2 and 4 weeks (p<0.001). Most scales for neurocognitive function were unchanged. Score for all Functional Assessment of Cancer Therapy-Brain (FACT-BR) subscales (measuring quality of life), except social=family well-being, were improved (p<0.05) at 2 and 4 weeks. Signiﬁcant changes in Eastern Cooperative Oncology Group (ECOG) performance status were noted, with 40% of patients improving at least one level. Modaﬁnil was well-tolerated with only one patient discontinuing treatment due to drug-related toxicity.
Conclusion: In this pilot study modaﬁnil was well-tolerated and effective for fatigue in patients with cancer. Improvements were also seen in mood, quality of life, and functional status.
Journal of Palliative Medicine
Volume 12, Number 5, 2009
Blackhall, M.D., M.T.S, et al