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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
136
Centre de Cancérologie Léon Bérard
Lyon, France
CHRU de Besançon, Site du CH Belfort-Montbéliard
Montbéliard, France
Centre Hospitalier Intercommunal de Créteil
Créteil, Île-de-France Region, France
APHP - Hôpital Tenon
Paris, Île-de-France Region, France
Institut de Cancérologie Gustave Roussy
Villejuif, Île-de-France Region, France
Incidence of grade 2 or higher oral mucositis
Differences of incidence of patients suffering of oral mucositis of grade 2 or higher
Time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Weight curve
Assessment of the weight curves for MUCIPLIQ and placebo groups
Time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
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