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Dose-Dependency of Antitumor Effects of the Pineal Hormone Melatonin in Untreatable Metastatic Solid Tumor Patients

Published on Sunday, 19 November 2023

Abstract

Despite it is known since more than 50 years that the pineal hormone melatonin (MLT) may play an anticancer activity, as confirmed by several experimental and clinical studies, the clinical use of MLT in the treatment of cancer is still at the beginning.

Most clinical studies have been performed with MLT dose of 20 mg/once daily in the dark period.

Preliminary clinical studies with MLT in untreatable advanced cancer patients have demonstrated an inhibitory effect on tumor progression, with a prolonged 1-year survival. However, at present it is still unknown whether the antitumor action of MLT may be a dose-dependent event in human neoplasms. This preliminary study was performed to evaluate the dose efficacy ratio of MLT in the treatment of human neoplasms.

The study was performed in 14 consecutive metastatic solid tumor patients, for whom no other standard antitumor therapy was available.

MLT was administered at a dose of 20 mg/day orally in the evening. In the case of progressive disease, MLT dose was progressively enhanced until 100 mg/day.

MLT therapy at a dose of 20 mg/day induced a disease control in 7/145 patients, consisting of partial response (PR) in one patient and a stable disease (SD) in other 6 patients.

After progression, dose increase of MLT until 100 mg induced again a SD in 6/14 (43%) and 1–year survival was achieved in 8/14 (56%).

The results of this preliminary study would demonstrate that the antitumor activity of MLT may increase by increasing MLT dose, and then it seems to be a dose-dependent phenomenon.

NOTE: This publication cites (Ref. N.3): L Di Bella, M T Rossi, G Scalera - Perspectives in pineal functions. Prog Brain Res. 1979:52:475-8. doi: 10.1016/s0079-6123(08)62954-4.

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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: Melatonin 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 - 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);

- Publication, 2020 Sep: Two neuroendocrine G protein-coupled receptor molecules, somatostatin and melatonin: Physiology of signal transduction and therapeutic perspectives (from Di Bella's Foundation);