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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Oral Mucositis Carcinoma in Situ of Upper Respiratory Tract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

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

MUCIPLIQ 0.05 mg/mL

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

Group Type EXPERIMENTAL

MUCIPLIQ

Intervention Type DEVICE

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

MUCIPLIQ 0.015 mg/mL

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

Group Type EXPERIMENTAL

MUCIPLIQ

Intervention Type DEVICE

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

Interventions

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MUCIPLIQ

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

Intervention Type DEVICE

Placebo

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient suffering from an upper aerodigestive tract carcinoma treated by radiotherapy alone or radiotherapy associated with a concomitant platine-salts-based chemotherapy ;
* Patient suffering of an upper aerodigestive tract carcinoma without entrance or located in the oral cavity, in the oropharynx or in the rhinopharynx ;
* Patient age of 18 years old or higher ;
* Writing informed consent to participate to the trial ;
* Patient affiliated to the French social security system.

Exclusion Criteria

* Treatment by non-standard fragmentation (concentrate irradiation)
* Carcinoma located in the hypopharynx or in the larynx ;
* Known hypersensitivity to heparinoids ;
* Patient who already benefited from a radiotherapy treatment ;
* Patient who already benefited from a chemotherapy treatment. Patients who benefited from neoadjuvant chemotherapy as part of their upper aerodigestive tract carcinoma care, may be included if it was held at least 4 weeks before the inclusion visit ;
* Patient participating to another biomedical research ;
* Pregnant woman, breastfeeding woman, parturient or likely to be ;
* Patient deprived of freedom, under supervision or guardianship ;
* Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No