Combination for the treatment of radiation- or chemotherapy-induced mucositis

Abstract

The present invention relates to the use of a combination of glycine, proline, and optionally a natural or synthetic film-forming polymer, and / or lysine and / or leucine, to prepare a composition for the treatment of mucositis induced by radiation or chemotherapy.

Description

[0001]The present invention relates to a combination of glycine, proline and optionally a natural or synthetic film-forming polymer, and / or lysine and / or leucine, for the treatment of mucositis induced by radiation or chemotherapy.TECHNICAL BACKGROUND[0002]Oral mucositis (OM) is one of the most frequent and potentially serious side effects of non-surgical antitumoral treatment (1,2). Clinically, it is characterised by erythema, formation of ulcers with or without pseudo-membranes, bleeding, formation of exudates, and / or infections located at the upper level (3), and can evolve into a debilitating form which adversely affects the patient's quality of life. The damage to the mucous membranes can extend from the oral cavity to the pharynx; in this invention, therefore, the term “oral mucositis” includes mucositis of the pharynx.[0003]The patient's perception of the symptoms associated with OM ranges from a sensation of pain in the mouth to impairment of various oral functions (4). OM c...

AI Technical Summary

Benefits of technology

The present invention relates to a combination of glycine, proline, and optionally a natural or synthetic film-forming polymer, lysine, and / or leucine for the treatment of oral mucositis induced by radiation or chemotherapy. The combination has been found to be effective in managing pain and promoting healing of ulcers in the mouth. The invention is based on the discovery that the combination of glycine and proline increases the gene expression of e-NO Synthase and controls the collagen synthesis by fibroblasts quantitatively. This combination is also efficient in suppressing TGF beta expression and preventing fibrotic collagen production. The invention provides a new treatment strategy for oral mucositis and the corresponding formulations.

Problems solved by technology

Clinically, it is characterised by erythema, formation of ulcers with or without pseudo-membranes, bleeding, formation of exudates, and / or infections located at the upper level (3), and can evolve into a debilitating form which adversely affects the patient's quality of life.

OM can be associated with pain symptoms such as dysgeusia, dysphagia, and difficulty in speaking, chewing or swallowing, with consequent impairment of the ability to eat, weight loss, and the need for feeding through a nasogastric tube.

All this not only has an adverse impact on the patient's quality of life, but can also lead to discontinuance of the treatment or a reduction in the dose of antitumoral medicament, with a consequent decline in the patient's life expectancy (5).

In financial terms, the frequent hospital admissions of patients suffering from OM, and their home care by personnel skilled in the administration of drugs or parenteral feeding, involve a considerable burden on the national health service (6,7).

Despite the severity and frequency of cases of OM and the many studies conducted on the subject, there is still no universally accepted standard strategy for the prevention and treatment of this potentially serious complication.

Although some trials have demonstrated that the onset of OM can be prevented or reduced, they were conducted on an insufficient number of participants, and do not meet adequate standards which allow the drafting of clinical practice guidelines (8-11).