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Non-Communicable Diseases Research Center, Sabzevar University of Medical Sciences, Sabzevar, Iran Zahra Keshtpour Amlashi, Faculty of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan, 6517838738, Iran. Emails: z.keshtpour@edu.umsha.ac.ir; zahraka6667@gmail.com

Seyed Alireza Javadinia, Vasei Educational Hospital, Sabzevar University of Medical Sciences, TohidShar Blv., Sabzevar, Razavi Khorasan 9617747431, Iran. Emails: javadiniaa941@mums.ac.ir; javadinia.alireza@gmail.com

Study concept and design: Z.K.A; acquisition of data: F.S. and A.S.P; analysis and interpretation of data: L.T. and S.A.J.; drafting of the manuscript: A.G.M. and T.H.; critical revision of the manuscript for important intellectual content: A.N.M. and S.M.J; statistical analysis: D.F. and S.N. The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

This research was funded by Hamadan University of Medical Sciences. Authors would like to thank all patients who participate in the project. Authors sincerely thank Vasei Clinical Research Development Unit in Sabzevar University of Medical Sciences, for providing advice and guidance in conducting this research. Also, this paper and the research behind it would not have been possible without the exceptional enthusiasm and help of Nurse Zahra Balali and Nurse Somayeh Tahmasebi.

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Research Funding:

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:

  • adjuvant treatment
  • breast cancer
  • fatigue
  • melatonin

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

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Journal Title:

INTEGRATIVE CANCER THERAPIES

Volume:

Volume 22

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Type of Work:

Article | Final Publisher PDF

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.

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© The Author(s) 2023

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/).
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