Carcinoma in Situ of Upper Respiratory Tract, Oral Mucositis
Conditions
Keywords
MUCIPLIQ, Matrix therapy, RGTA, Oral mucositis
Brief 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.
Interventions
DEVICEMUCIPLIQ
MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
DEVICEPlacebo
Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
Sponsors
Organ, Tissue, Regeneration, Repair and Replacement
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 2 or higher oral mucositis | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | Differences of incidence of patients suffering of oral mucositis of grade 2 or higher |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Terms of grade 2 or higher oral mucositis | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | Differences of number and terms of oral mucositis of grade 2 or higher between MUCIPLIQ and placebo groups |
| Administered-antalgics posology and nature | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | Differences of administered-antalgics posology and nature between MUCIPLIQ and placebo groups |
| Pain experienced in time | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | Differences of pain experienced by patients between MUCIPLIQ and placebo groups, assessed with Numerical Pain Scale (0 to 10). |
| Assessment of the Oral Health Impact Profile | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | Assessment of the Oral Health Impact Profile assessed by the OHIP-14 questionnaire between MUCIPLIQ and placebo groups |
| Weight curve | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks | Assessment of the weight curves for MUCIPLIQ and placebo groups |
Countries
France
Outcome results
None listed