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A Randomized Study of High-Dose Pineal Hormone Melatonin Alone Versus High-Dose Melatonin Plus Low-Dose Angiotensin-(1-7) in Untreatable Advanced Cancer Patients

Published on Friday, 28 April 2023

Abstract

The recent advances in the knowledge of the neuroendocrine control of the immune system and cancer growth have demonstrated the existence of several anticancer natural molecules in the human body, the most promising of them are the pineal hormone melatonin (MLT) and the enzymatic product of ACE2, the angiotensin 1-7 (Ang 1-7).

Both MLT and Ang 1-7 have no toxicity, and they exert their antitumor action through several mechanisms, including inhibition of cancer cell proliferation and angiogenesis, and stimulation of the anticancer immunity.

Previous preliminary clinical studies had already shown that high-dose MLT may induce a disease control in advanced cancer patients eligible for the only palliative therapy.

The present study was performed to evaluate whether the concomitant administration of Ang 1-7 may furtherly increase the antitumor efficacy of MLT in untreatable cancer patients suffering from various tumour histotypes.

The study included 70 consecutive advanced untreatable cancer patients, who were randomized to receive the only best supportive care, high-dose MLT (100 mg/day in the dark period), or MLT plus Ang 1-7 (0.5 mg twice/day).

The percentage of disease control (DC), including stable disease and tumor regressions, achieved in patients treated by MLT plus Ang 1-7 was significantly higher with respect to those obtained in patients treated with MLT alone (P < 0.05) or with the only supportive care (P < 0.001).

No toxicity was seen under therapy of MLT plus Ang 1-7.

In contrast, most patients experienced mood improvement, a diminished anxiety, and a relief of asthenia, which was more evident in patients concomitantly treated by MLT and Ang 1-7.

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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 Variable Part - Omega 3 Essential/Unsaturated Fatty Acids. From 1.5 grams up to 3.0 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);