The aim of this study was to compare the efficacy and safety of modafinil and dexamethasone in the management of cancer-related fatigue and their effects on quality of life (QoL). A prospective randomized controlled study was conducted, enrolling 80 cancer patients experiencing moderate or severe fatigue following at least three cycles of chemotherapy or a course of palliative/curative radiotherapy. Patients received either oral modafinil 100 mg or dexamethasone 4 mg daily for 14 days. Levels of fatigue, QoL and symptom severity were compared after 14–21 days. Both drugs were efficacious and safe in the management of fatigue and QoL. However, modafinil performed marginally better. Although modafinil demonstrated marginal superiority, both modafinil and dexamethasone can improve fatigue and QoL in cancer patients.

Clinical trials registry of India: CTRI/2018/05/014046 (www.ctri.nic.in)

Lay abstract

Cancer-related fatigue is a common and nagging problem that needs best evidence-based management. Modafinil, a brain stimulant, and dexamethasone, a corticosteroid, have been shown in separate studies to provide benefit, but there are little data regarding which one is superior. The present study compared modafinil with dexamethasone in a randomized controlled trial. Modafinil was found to be marginally superior in treating cancer-related fatigue and several domains of quality of life, though dexamethasone also demonstrated significant improvement of fatigue. This study provides a valuable guide for future larger studies for implementation of the findings in the form of better patient care.

Tweetable abstract

Oral doses of the #psychostimulant #modafinil and #corticosteroid #dexamethsasone can improve #cancer-related #fatigue and #qualityoflife without major #sideeffects. #Modafinil was marginally superior.

Keywords:

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Vol. 17, No. 14

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History

Received 20 August 2020

Accepted 8 January 2021

Published online 2 March 2021

Published in print May 2021

Information

Keywords

Author contributions

Conception and design of the study: S Mukhopadhyay, U Deb, S Banerjee and S Biswas. Data collection: U Deb, B Bhattacharya and S Banerjee. Data analysis: U Deb and S Mukhopadhyay. Manuscript preparation: U Deb and S Mukhopadhyay. Interpretation of findings, critical review and revision of the manuscript: S Mukhopadhyay, U Deb, B Bhattacharya, S Banerjee and S Biswas. All authors read and approved the final manuscript and agree to be accountable for all aspects of the work.

Acknowledgments

The authors sincerely acknowledge FACIT.org for providing free license of FACIT-F and FACIT-Fatigue scales for using in this academic research. The authors also thank Dr. D Das, Dr. P Dutta and Dr. Aditya of the Department of Radiation Oncology and S Dutta of the Department of Pharmacology, Burdwan Medical College, Burdwan, India.

Financial & competing interests disclosure

This study was funded by the Indian Council of Medical Research (no. 3/2/Jan; 2018/PG-Thesis-HRD(10); date: 7.9.201). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

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