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A Preliminary Phase-2 Study with very High-Dose of Melatonin (1000 mg/day) in Untreatable Advanced Cancer Patients Already Progression on Previous Palliative Therapy with High-Dose Melatonin

Published on Sunday, 15 October 2023

Abstract

It is known since more than 50 years that the pineal gland plays a fundamental role in the natural biological resistance against cancer onset and growth. The anticancer role of the pineal gland is due to the production of several antitumor molecules, the most known of them is the indole hormone melatonin (MLT).

Unfortunately, although there are a lot of experimental evidences that MLT is completely non-toxic, no oncologist seem to be interested to the clinical use of MLT in the treatment of human neoplasms, at least from a palliative point of view. However, a few number of clinical studies of MLT in the complementary treatment of cancer has demonstrated that the anticancer activity of MLT is a dose-dependent phenomenon.

On this basis, a preliminary study with a very high dose of MLT, consisting of 1000 mg/once day in the evening, was carried out in untreatable cancer patients, who failed to respond to the conventional anticancer therapies, and for whom the only available treatment was the palliative therapy.

The treatment was well tolerated, and a disease control was achieved in 54% patients.

These preliminary results would justify further clinical studies to generate a new interpretation of cancer control, consisting of the pharmacological reproduction of the same mechanisms responsible for the natural resistance against cancer development.

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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);