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

NCT01840436 | Completed DMC

• 1 other identifier: CT11M10MURT
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 5

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.

Conditions

Oral Mucositis; Carcinoma in Situ of Upper Respiratory Tract

Keywords

MUCIPLIQ; Matrix therapy; RGTA; Oral mucositis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number and Terms of grade 2 or higher oral mucositis

  Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks

• Administered-antalgics posology and nature

  Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks

• Pain experienced in time

  Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks

• Assessment of the Oral Health Impact Profile

  Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks

• Weight curve

  Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

This arm receives a placebo (saline solution) mouthwash treatment twice a day.

Device: Placebo

MUCIPLIQ 0.05 mg/mL

EXPERIMENTAL

This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day.

Device: MUCIPLIQ

MUCIPLIQ 0.015 mg/mL

EXPERIMENTAL

This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day.

Device: MUCIPLIQ

Interventions

MUCIPLIQ DEVICE

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

MUCIPLIQ 0.015 mg/mL; MUCIPLIQ 0.05 mg/mL

Placebo DEVICE

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Organ, Tissue, Regeneration, Repair and Replacement: lead

Study Sites (5)

Centre de Cancérologie Léon Bérard

Lyon, 69373, France

Location

CHRU de Besançon, Site du CH Belfort-Montbéliard

Montbéliard, 25200, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, Île-de-France Region, 94010, France

Location

APHP - Hôpital Tenon

Paris, Île-de-France Region, 75970, France

Location

Institut de Cancérologie Gustave Roussy

Villejuif, Île-de-France Region, 94800, France

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 25, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

FR (5)