Spots Global Cancer Trial Database for Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer

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Trial Identification

Brief Title: Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer

Official Title: A Randomized Controlled Study Evaluating the Effect of MUCIPLIQ Versus Placebo on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering of Upper Aerodigestive Tract Carcinomas

Study ID: NCT01840436

Conditions

Oral Mucositis

Carcinoma in Situ of Upper Respiratory Tract

Interventions

MUCIPLIQ

Placebo

Study Description

Brief Summary: MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as extracellular matrix, by binding to structural proteins, and 2) in cells communication process by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix scaffold and cells communication, a process known as Matrix Therapy. The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of upper aerodigestive tract cancers, when used as a preventive agent. The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.

Detailed Description: