Melatonin with adenosine solubilized in water and stabilized with glycine for oncological treatment - technical preparation, effectivity and clinical findings

Abstract

Melatonin has shown the potential to inhibit growth of different tumors, both in vitro and in vivo.

There is clear evidence that the administration of melatonin alone or in combination with chemo and radiotherapy in cancer patients with advanced solid tumors has been associated with improved outcomes of tumor regression and survival.

Moreover, chemotherapy has been shown to be better tolerated in patients treated with melatonin.

However, there are different ways of preparation and administration of melatonin to the patient.

This review article aims to offer the insight into the preparation, biological features and clinical findings in its use in cancer patients.

Melatonin (MLT) can only be solubilized in water at 40-45 °C; at other temperatures it can only be solubilized in alcohol. It is absorbed in the human body complexed with adenosine by a hydrogen bond.

It acts on two common denominators: proliferation and differentiation; in addition to anticancer homeostasis, MLT has a documented antidegenerative and immunomodulatory role.

It also plays an important role in limiting oxidative stress, affecting blood and bone marrow constituent ratio, leukocyte formula regulation, hemoglobin synthesis, platelet genesis, aggregation and in erythrocyte resistance.

Despite of all these important roles, most well-known features are probably the least important ones, such as sleep and wakefulness regulation and its effect on jet lag.

In the preparation formulated by Prof. Di Bella, melatonin with adenosine at a ratio of 1:4, stabilized with 30% of glycine (MLT-DBM), has been used since 1994 in many patients with various indications and positive therapeutic responses and a total absence of toxicity.

This method can be a good alternative to commercially produced preparations, as it was scientifically proved and published worldwide at conferences and in various medical journals.

About this publication.

NOTE: Luigi Di Bella has filed for patent to protect the following invention: Method of production of essentially pure melatonin and the method of solubilizing melatonin in water.

• United States Patent RE35,631;
• Inventors: Fraschini Franco (Milan, IT), Di Bella Luigi (Milan, IT), Duranti Ermanno (Milan, IT), Duranti Maria Teresa Moni (legal representative, Urbino, IT), Duranti Andrea (legal representative, Urbino, IT), Duranti Lucia (legal representative, Urbino, IT);
• Assignee: IFLO S.A.S. (Milan, IT);
• Appl. No.: 08/252,905
• Filed: June 2, 1994

See below for this patent, click here and/or here.

See also:

- About Melatonin;

- The Di Bella Method (A Fixed Part - Melatonin tablets);

- Congenital fibrosarcoma in complete remission with Somatostatin, Retinoids, Vitamin D3, Vitamin E, Vitamin C, Melatonin, Calcium, Chondroitin sulfate associated with low doses of Cyclophosphamide in a 14-year Follow Up;

- The Di Bella Method (DBM) in the treatment of prostate cancer: a preliminary retrospective study of 16 patients and a review of the literature;

- Oesophageal squamocellular carcinoma: a complete and objective response;

- Cyclophosphamide plus Somatostatin, Bromocriptin, Retinoids, Melatonin and ACTH in the Treatment of Low-grade Non-Hodgkin’s Lymphomas at Advanced Stage: Results of a Phase II Trial;

- Relapse of High-Grade Non-Hodgkin’s Lymphoma After Autologous Stem Cell Transplantation: A Case Successfully Treated With Cyclophosphamide Plus Somatostatin, Bromocriptine, Melatonin, Retinoids, and ACTH;

- Low-grade Non-Hodgkin Lymphoma at Advanced Stage: A Case Successfully Treated With Cyclophosphamide Plus Somatostatin, Bromocriptine, Retinoids, and Melatonin;

- The Di Bella Method (DBM) improved survival, objective response and performance status in a retrospective observational clinical study on 55 cases of Lymphomas;

- Large B-cells Non-Hodgkin's Lymphoma, Stage IV-AE: a Case Report;

- Non-Hodgkin's Lymphoma, Stage III-B-E: a Case Report;

- Neuroblastoma: Complete objective response to biological treatment;

- Somatostatin, retinoids, melatonin, vitamin D, bromocriptine, and cyclophosphamide in advanced non-small-cell lung cancer patients with low performance status;

- Somatostatin, retinoids, melatonin, vitamin D, bromocriptine, and cyclophosphamide in chemotherapy-pretreated patients with advanced lung adenocarcinoma and low performance status;

- Observations on the Report of a case of pulmonary adenocarcinoma with lymph node, hepatic and osseus metastasis;

- Chronic Lymphocytic Leukemia: Long-Lasting Remission with Combination of Cyclophosphamide, Somatostatin, Bromocriptine, Retinoids, Melatonin, and ACTH;

- The Di Bella Method DBM improved survival objective response and performance status in a retrospective observational clinical study on 23 tumours of the head and neck;

- Recurrent Glioblastoma Multiforme (grade IV – WHO 2007): a case of complete objective response achieved by means of the concomitant administration of Somatostatin and Octreotide – Retinoids – Vitamin E – Vitamin D3 – Vitamin C – Melatonin – D2 R agonists (Di Bella Method – DBM) associated with Temozolomide;

- Complete objective response, stable for 5 years, with the Di Bella Method, of multiple-metastatic carcinoma of the breast;

- Evaluation of the safety and efficacy of the first-line treatment with somatostatin combined with melatonin, retinoids, vitamin D3, and low doses of cyclophosphamide in 20 cases of breast cancer: a preliminary report;

- The Di Bella Method (DBM) improved survival, objective response and performance status in a retrospective observational clinical study on 122 cases of breast cancer;

- Complete objective response to biological therapy of plurifocal breast carcinoma.