Targeting Side Effects Associated with Androgen Deprivation Therapy Using Melatonin: A Randomized Trial on Hot Flashes and Sexual Health in Prostate Cancer Patients

Document Type : Research Articles

Authors

1 Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.

2 Department of Internal Medicine, Oncology and Hematology Section, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

3 Cancer Prevention Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

Abstract

Objective: The aim of this study was to examine melatonin as a potential adjunct therapy for managing treatment-related symptoms in prostate cancer patients, particularly those undergoing androgen deprivation therapy (ADT). Methods: In light of the increasing incidence of prostate cancer among younger males, this randomized, double-blind, placebo-controlled clinical trial was conducted at the Hematology-Oncology Center of Omid Hospital in Isfahan, Iran, between October 2019 and October 2020. Forty-one prostate cancer patients experiencing hot flashes or sexual dysfunction due to ADT were randomly assigned to receive either melatonin (3 mg twice daily) or a placebo for four weeks. Symptom assessment was performed using the Hot Flash Diary, the International Index of Erectile Function (IIEF), and the Functional Assessment of Cancer Therapy–Prostate (FACT-P) questionnaire. Result: The results showed a statistically significant improvement in FACT-P scores within the melatonin group (P < 0.05), while erectile function scores increased modestly in both groups without reaching statistical significance (P > 0.05). The most pronounced effect was observed in the reduction of the frequency of mild hot flashes in the melatonin group, with significant improvements noted by week four (P < 0.05). Melatonin was well tolerated, with no clinically significant adverse events reported. These findings suggest that melatonin may effectively alleviate vasomotor symptoms and enhance the quality of life in prostate cancer patients undergoing ADT. However, its impact on sexual function remains inconclusive. Conclusion: Further large-scale, long-term studies incorporating mechanistic endpoints are needed to validate these findings and inform clinical guidelines for melatonin use in supportive prostate cancer care. 

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Asian Pacific Journal of Cancer Prevention
Volume 27, Issue 2
February 2026
Pages 453-462

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History

  • Receive Date: 13 December 2024
  • Revise Date: 21 October 2025
  • Accept Date: 26 January 2026

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