Clinical trial NCT01840436: Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Carcinoma in Situ of Upper Respiratory Tract
Keywords: MUCIPLIQ
Matrix therapy
RGTA
Oral mucositis
Lead sponsor: Organ, Tissue, Regeneration, Repair and Replacement
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of grade 2 or higher oral mucositis
timeFrame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Secondary outcomes:
measure: Number and Terms of grade 2 or higher oral mucositis
timeFrame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
measure: Administered-antalgics posology and nature
timeFrame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
measure: Pain experienced in time
timeFrame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
measure: Assessment of the Oral Health Impact Profile
timeFrame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
measure: Weight curve
timeFrame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
state: Ile de France
city: Paris
country: France
facility: APHP - Hôpital Tenon
state: Ile de France
city: Villejuif
country: France
facility: Institut de Cancérologie Gustave Roussy
state: Ile de France
city: Lyon
country: France
facility: Centre de Cancérologie Léon Bérard
city: Montbéliard
country: France
facility: CHRU de Besançon, Site du CH Belfort-Montbéliard
Study officials:
affiliation: Institut Gustave Roussy, Villejuif, France
name: Nicolas Daly-Schveitzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Gustave Roussy, Villejuif, France
name: Yungan Tao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Organ, Tissue, Regeneration, Repair and Replacement
name: Denis BARRITAULT, PhD
role: STUDY_DIRECTOR
References: