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

Organ, Tissue, Regeneration, Repair and Replacement

Status: Completed

Conditions: Carcinoma in Situ of Upper Respiratory Tract; Oral Mucositis

Treatments: Device: Placebo; Device: MUCIPLIQ

Study type: Interventional

Funder types: Industry

Identifiers

NCT01840436

CT11M10MURT

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo

MUCIPLIQ 0.05 mg/mL

Experimental group

Description:

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

Treatment:

Device: MUCIPLIQ

MUCIPLIQ 0.015 mg/mL

Experimental group

Description:

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

Treatment:

Device: MUCIPLIQ