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

NCT01840436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-05-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Organ, Tissue, Regeneration, Repair and Replacement

    lead INDUSTRY

Principal Investigators

  • Nicolas Daly-Schveitzer, MD, PhD · Institut Gustave Roussy, Villejuif, France

  • Yungan Tao, MD · Institut Gustave Roussy, Villejuif, France

  • Denis BARRITAULT, PhD · Organ, Tissue, Regeneration, Repair and Replacement

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01840436 on ClinicalTrials.gov