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

Study Overview
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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.

Official Title
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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

Conditions
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Oral Mucositis, Carcinoma in Situ of Upper Respiratory Tract

Intervention / Treatment
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* Device: MUCIPLIQ
* Device: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>This arm receives a placebo (saline solution) mouthwash treatment twice a day. | Device: Placebo<br>* Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.<br>|
| Experimental: MUCIPLIQ 0.05 mg/mL<br>This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day. | Device: MUCIPLIQ<br>* MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.<br>|
| Experimental: MUCIPLIQ 0.015 mg/mL<br>This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day. | Device: MUCIPLIQ<br>* MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade 2 or higher oral mucositis | Differences of incidence of patients suffering of oral mucositis of grade 2 or higher | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Terms of grade 2 or higher oral mucositis | Differences of number and terms of oral mucositis of grade 2 or higher between MUCIPLIQ and placebo groups | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | 
| Administered-antalgics posology and nature | Differences of administered-antalgics posology and nature between MUCIPLIQ and placebo groups | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | 
| Pain experienced in time | Differences of pain experienced by patients between MUCIPLIQ and placebo groups, assessed with Numerical Pain Scale (0 to 10). | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | 
| Assessment of the Oral Health Impact Profile | Assessment of the Oral Health Impact Profile assessed by the OHIP-14 questionnaire between MUCIPLIQ and placebo groups | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | 
| Weight curve | Assessment of the weight curves for MUCIPLIQ and placebo groups | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MUCIPLIQ, Matrix therapy, RGTA, Oral mucositis