Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer

Oral Mucositis Clinical Trial

— MUCIPLIQ  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840436
• Other study ID #: CT11M10MURT
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: May 4, 2016
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2016
• Source: Organ, Tissue, Regeneration, Repair and Replacement
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesFrance: Conseil National de l'Ordre des Médecins
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma in Situ
• Carcinoma in Situ of Upper Respiratory Tract
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Device:
• MUCIPLIQ
MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
• Placebo
Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Créteil	Créteil	Ile de France
France	Centre de Cancérologie Léon Bérard	Lyon
France	CHRU de Besançon, Site du CH Belfort-Montbéliard	Montbéliard
France	APHP - Hôpital Tenon	Paris	Ile de France
France	Institut de Cancérologie Gustave Roussy	Villejuif	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Organ, Tissue, Regeneration, Repair and Replacement

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Administered-antalgics posology and nature	Differences of administered-antalgics posology and nature between MUCIPLIQ and placebo groups	Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Weight curve	Assessment of the weight curves for MUCIPLIQ and placebo groups	Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks	No