MUCIPLIQ
DeviceMUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
NCT Number: NCT01840436
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Centre Hospitalier Intercommunal de Créteil, Créteil, Île-de-France Region, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
Time frame: 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
Time frame: 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
Time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
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
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 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
Assessment of the weight curves for MUCIPLIQ and placebo groups
Organ, Tissue, Regeneration, Repair and Replacement
Industry
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
Acronym: MUCIPLIQ
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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