Home page News Related Researches 2020-2029

Melatonin in the Management of Mood and Sleep Problems Induced by Androgen Deprivation Therapy in Prostate Cancer Patients: A Randomized Double-blinded, Placebo-controlled Clinical Trial

Published on Friday, 24 March 2023

Abstract

Background: Androgen deprivation therapy (ADT) has been considered as a mainstay of treatment for advanced prostate cancer. Considering ADT for cancer patients is accompanied with many side effects, such as behavioral and neurologic side effects that adversely affect the quality of life.

Objectives: This study aimed to evaluate the effects of melatonin administration on sleep problems and mood changes induced by ADT in prostate cancer patients.

Methods: The randomized, double-blind, placebo-controlled trial was designed in the oncology-hematology outpatient clinic of Omid Hospital, Isfahan, Iran. After screening by the hospital anxiety and depression scale (HADS), patients were divided into either an intervention group receiving 6 mg melatonin daily for four weeks or an identical placebo. After that, patients were evaluated by the Pittsburgh sleep quality index (PSQI), the Hamilton Anxiety Rating Scale (HAM-A), and Beck Depression Inventory (BDI) questionnaires at baseline and after 4-week follow-ups.

Results: Forty-three patients, including 21 and 22 patients in melatonin and placebo groups, respectively completed follow-ups period. Melatonin administration significantly improved PSQI scores in four domains of sleep quality, sleep latency, sleep efficacy, and daytime dysfunction. After 4-week melatonin supplementation, the severity of depression and anxiety assessed by BDI and HAM-A questionnaires, respectively, decreased non-statistically significant in both melatonin and placebo groups.

Conclusions: In our study, melatonin supplementation ameliorated ADT-induced sleep problems in patients with prostate cancers; however, for more conclusive results, further future large and well-designed clinical studies is warranted.

Download the complete article

About this publication.

- The Di Bella Method (A Fixed Part - Melatonin tablets. From 30-40mg/day up to 200mg/day orally in patients with advanced stage of cancer disease and/or patients without respond to traditional treatments);

- Melatonin use in cancer patients have started in 1974, when melatonin prepared according to Prof. Di Bella’s formulation [...]. For 11 days was administered to the patient, admitted to the general medical ward at the Maggiore-Pizzardi Hospital in Bologna, very slowly (over approx. 8 hours) and intravenously administered 1000 mg of melatonin for 11 days. During the course of each day, the patient was intravenously administered 4 saline drips of 500 ml, each containing ten 25 mg bottles of freeze-dried melatonin, lasting 2 hours, totaling 1000 mg per day. No other drug of any kind was administered in order to ascertain the effect of the MLT without interference [...]. From Melatonin with adenosine solubilized in water and stabilized with glycine for oncological treatment - technical preparation, effectivity and clinical findings;

- About Melatonin - In vitro, review and in vivo publications;

- Publication: Melmethoatonin anticancer effects: Review (from Di Bella's Foundation);

- Publication: Key aspects of melatonin physiology: 30 years of research (from Di Bella's Foundation);

- The Di Bella Method (A Fixed Part - Cyclophosphamide 50mg tablets and/or Hydroxyurea 500mg tablets, one or two per day);

- The Di Bella Method (A Fixed Part - Calcium, 2 grams per day, orally);

- The Di Bella Method (A Fixed Part - Somatostatin, Octreotide, Sandostatin LAR, analogues and/or derivatives);

- Somatostatin in oncology, the overlooked evidences - In vitro, review and in vivo publications;

- Publication, 2018 Jul: Over-Expression of GH/GHR in Breast Cancer and Oncosuppressor Role of Somatostatin as a Physiological Inhibitor (from Di Bella's Foundation);

- Publication, 2018 Sep: The over-expression of GH/GHR in tumour tissues with respect to healthy ones confirms its oncogenic role and the consequent oncosuppressor role of its physiological inhibitor, somatostatin: a review of the literature (from Di Bella's Foundation);

- Publication, 2019 Aug: The Entrapment of Somatostatin in a Lipid Formulation: Retarded Release and Free Radical Reactivity (from Di Bella's Foundation);

- Publication, 2019 Sep: Effects of Somatostatin and Vitamin C on the Fatty Acid Profile of Breast Cancer Cell Membranes (from Di Bella's Foundation);

- Publication, 2019 Sep: Effects of somatostatin, curcumin, and quercetin on the fatty acid profile of breast cancer cell membranes (from Di Bella's Foundation);