A Randomized, Controlled, Parallel-Group, Trial on the Long-term Effects of Melatonin on Fatigue Associated With Breast Cancer and Its Adjuvant Treatments

• Type of Material: Article
• Authors: Abdolazim Sedighi Pashaki, Hamadan University of Medical Sciences; Fateme Sheida, University of Medical Sciences; Leila Moaddab Shoar, Ministry of Health and Medical Education, Tehran, Iran; Tahereh Hashem, University of Medical Sciences, Hamadan, Iran; Danial Fazilat-Panah, University of Medical Sciences, Babol, Iran; Alireza Nemati Motehaver, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Ali Ghanbari Motlagh, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Safoora Nikzad, Hamadan University of Medical Sciences; Mojtaba Bakhtiari, Emory University; Leili Tapak, Hamadan University of Medical Sciences; Zahir Keshtpour Amlashi, Golestan University of Medical Sciences, Gorgan, Iran; Seyed Alireza Javadinia, Sabzevar University of Medical Sciences; Zahra Keshtpour Amlashi, University of Medical Sciences, Hamadan, Iran
• Language: English
• Date: 2023-05-04
• Publisher: SAGE Publications (UK and US)
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2023
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1177/15347354231168624
• Title of Journal or Parent Work: INTEGRATIVE CANCER THERAPIES
• Volume: 22
• Grant/Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was fully funded by Hamadan University of Medical Sciences which is an academic and research institution where research and education are the primary function of the entity (grant number: 37649 to Z.K.A.). The funder had no role in the design of the study, the collection, analysis, and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication.
• Keywords: breast cancer; melatonin; fatigue; adjuvant treatment
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

Objective: Cancer related fatigue is a distressing condition and correlated with decrease in quality of life of patients with malignant conditions. In continuation of our previous research, we assessed long term anti-fatigue effects of melatonin in patients with the breast cancer. Material and methods: In this clinical trial, 92 breast cancer patients were randomly assigned to receive either melatonin (18 mg/day) or placebo from 1 week before the adjuvant treatments until 2 years after their completion. The levels of fatigue were assessed before and after intervention using Brief Fatigue Inventory (BFI) and were compared at a significance level of P ≤ .05. Results: The BFI scores were similar between the 2 groups at the baseline (placebo group: 5.56 ± 1.59 and melatonin group: 5.72 ± 1.68, P = .67). After the intervention, not only the mean fatigue score was significantly lower in melatonin group (2.93 ± 1.04 vs 1.99 ± 1.02, P < .001, P ≤ .05), but also a greater reduction in fatigue score in intervention group was evident over time (P ≤ .001). Conclusion: Long-term usage of melatonin even after completion of adjuvant therapies in women with breast cancer decreased the levels of fatigue associated with the malignant condition and its treatments.