Clinical trial · Interventional
Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma in Situ of Upper Respiratory Tract | — | UNRESOLVED | — |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MUCIPLIQ | Device | — | UNRESOLVED |
| Placebo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- This arm receives a placebo (saline solution) mouthwash treatment twice a day.
- interventionNames
- Device: Placebo
- type
- EXPERIMENTAL
- label
- MUCIPLIQ 0.05 mg/mL
- description
- This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day.
- interventionNames
- Device: MUCIPLIQ
- type
- EXPERIMENTAL
- label
- MUCIPLIQ 0.015 mg/mL
- description
- This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available