Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | This arm receives a placebo (saline solution) mouthwash treatment twice a day. |
|
| MUCIPLIQ 0.05 mg/mL | Experimental | This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day. |
|
| MUCIPLIQ 0.015 mg/mL | Experimental | This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MUCIPLIQ | Device | MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 2 or higher oral mucositis | Differences of incidence of patients suffering of oral mucositis of grade 2 or higher | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks |
| Administered-antalgics posology and nature |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Daly-Schveitzer, MD, PhD | Institut Gustave Roussy, Villejuif, France | Principal Investigator |
| Yungan Tao, MD | Institut Gustave Roussy, Villejuif, France | Principal Investigator |
| Denis BARRITAULT, PhD | Organ, Tissue, Regeneration, Repair and Replacement | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Cancérologie Léon Bérard | Lyon | 69373 | France | |||
| CHRU de Besançon, Site du CH Belfort-Montbéliard |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Device | Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day. |
|
Differences of administered-antalgics posology and nature between MUCIPLIQ and placebo groups |
| 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). | 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 | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks |
| Weight curve | Assessment of the weight curves for MUCIPLIQ and placebo groups | Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks |
| Montbéliard |
| 25200 |
| France |
| Centre Hospitalier Intercommunal de Créteil | Créteil | Île-de-France Region | 94010 | France |
| APHP - Hôpital Tenon | Paris | Île-de-France Region | 75970 | France |
| Institut de Cancérologie Gustave Roussy | Villejuif | Île-de-France Region | 94800 | France |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided