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

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

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.

Study Overview

• Status: Completed
• Conditions: Oral Mucositis; Carcinoma in Situ of Upper Respiratory Tract
• Intervention / Treatment: Device: Placebo; Device: MUCIPLIQ

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69373
    • Centre de Cancérologie Léon Bérard
  • Montbéliard, France, 25200
    • CHRU de Besançon, Site du CH Belfort-Montbéliard
  • Ile de France
    • Créteil, Ile de France, France, 94010
      • Centre Hospitalier Intercommunal de Creteil
    • Paris, Ile de France, France, 75970
      • APHP - Hôpital Tenon
    • Villejuif, Ile de France, France, 94800
      • Institut de Cancérologie Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; This arm receives a placebo (saline solution) mouthwash treatment twice a day.	Device: Placebo; Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
EXPERIMENTAL: MUCIPLIQ 0.05 mg/mL; This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day.	Device: MUCIPLIQ; MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
EXPERIMENTAL: MUCIPLIQ 0.015 mg/mL; This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day.	Device: MUCIPLIQ; MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Organ, Tissue, Regeneration, Repair and Replacement
• Investigators: Principal Investigator: Nicolas Daly-Schveitzer, MD, PhD, Institut Gustave Roussy, Villejuif, FRANCE; Principal Investigator: Yungan Tao, MD, Institut Gustave Roussy, Villejuif, FRANCE; Study Director: Denis BARRITAULT, PhD, Organ, Tissue, Regeneration, Repair and Replacement

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (ESTIMATE): April 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Oral mucositis; Matrix therapy; MUCIPLIQ; RGTA
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Carcinoma in Situ; Carcinoma; Mucositis; Stomatitis
• Other Study ID Numbers: CT11M10MURT