NCT01840436

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Organ, Tissue, Regeneration, Repair and Replacement · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Mucositis
• Carcinoma in Situ of Upper Respiratory Tract

Interventions

Type	Name	Description
DEVICE	MUCIPLIQ	MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
DEVICE	Placebo	Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-04-25
• Last updated: 2016-05-05

Locations

5 sites across 1 country: France