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This arm receives a placebo (saline solution) mouthwash treatment twice a day.

This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day.

This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day.

MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.

MUCIPLIQ

Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.

Placebo

Nicolas Daly-Schveitzer, MD, PhD

Yungan Tao, MD

Denis BARRITAULT, PhD

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.

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

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

Differences of incidence of patients suffering of oral mucositis of grade 2 or higher

Differences of number and terms of oral mucositis of grade 2 or higher between MUCIPLIQ and placebo groups

Differences of administered-antalgics posology and nature between MUCIPLIQ and placebo groups

Differences of pain experienced by patients between MUCIPLIQ and placebo groups, assessed with Numerical Pain Scale (0 to 10).

Assessment of the Oral Health Impact Profile assessed by the OHIP-14 questionnaire between MUCIPLIQ and placebo groups

Assessment of the weight curves for MUCIPLIQ and placebo groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer	NCT01840436	Oral Mucositis Carcinoma in Si...	MUCIPLIQ Placebo	18 Years -	Organ, Tissue, Regeneration, Repair and Replacement
Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer	NCT01840436	Oral Mucositis Carcinoma in Si...	MUCIPLIQ Placebo	18 Years -	Organ, Tissue, Regeneration, Repair and Replacement

Spots Global Cancer Trial Database for rgta

Every month we try and update this database with for rgta cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rgta

Every month we try and update this database with for rgta cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rgta cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.