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

Primary Purpose

Oral Mucositis, Carcinoma in Situ of Upper Respiratory Tract

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MUCIPLIQ
Placebo
Sponsored by
Organ, Tissue, Regeneration, Repair and Replacement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring MUCIPLIQ, Matrix therapy, RGTA, Oral mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Intercommunal de Créteil
  • APHP - Hôpital Tenon
  • Institut de Cancérologie Gustave Roussy
  • Centre de Cancérologie Léon Bérard
  • CHRU de Besançon, Site du CH Belfort-Montbéliard

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

MUCIPLIQ 0.05 mg/mL

MUCIPLIQ 0.015 mg/mL

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Incidence of grade 2 or higher oral mucositis
Differences of incidence of patients suffering of oral mucositis of grade 2 or higher

Secondary Outcome Measures

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
Administered-antalgics posology and nature
Differences of administered-antalgics posology and nature between MUCIPLIQ and placebo groups
Pain experienced in time
Differences of pain experienced by patients between MUCIPLIQ and placebo groups, assessed with Numerical Pain Scale (0 to 10).
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
Weight curve
Assessment of the weight curves for MUCIPLIQ and placebo groups

Full Information

First Posted
April 23, 2013
Last Updated
May 4, 2016
Sponsor
Organ, Tissue, Regeneration, Repair and Replacement
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1. Study Identification

Unique Protocol Identification Number
NCT01840436
Brief Title
Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organ, Tissue, Regeneration, Repair and Replacement

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis, Carcinoma in Situ of Upper Respiratory Tract
Keywords
MUCIPLIQ, Matrix therapy, RGTA, Oral mucositis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This arm receives a placebo (saline solution) mouthwash treatment twice a day.
Arm Title
MUCIPLIQ 0.05 mg/mL
Arm Type
Experimental
Arm Description
This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day.
Arm Title
MUCIPLIQ 0.015 mg/mL
Arm Type
Experimental
Arm Description
This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day.
Intervention Type
Device
Intervention Name(s)
MUCIPLIQ
Intervention Description
MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
Primary Outcome Measure Information:
Title
Incidence of grade 2 or higher oral mucositis
Description
Differences of incidence of patients suffering of oral mucositis of grade 2 or higher
Time Frame
Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Secondary Outcome Measure Information:
Title
Number and Terms of grade 2 or higher oral mucositis
Description
Differences of number and terms of oral mucositis of grade 2 or higher between MUCIPLIQ and placebo groups
Time Frame
Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Title
Administered-antalgics posology and nature
Description
Differences of administered-antalgics posology and nature between MUCIPLIQ and placebo groups
Time Frame
Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Title
Pain experienced in time
Description
Differences of pain experienced by patients between MUCIPLIQ and placebo groups, assessed with Numerical Pain Scale (0 to 10).
Time Frame
Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Title
Assessment of the Oral Health Impact Profile
Description
Assessment of the Oral Health Impact Profile assessed by the OHIP-14 questionnaire between MUCIPLIQ and placebo groups
Time Frame
Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Title
Weight curve
Description
Assessment of the weight curves for MUCIPLIQ and placebo groups
Time Frame
Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Daly-Schveitzer, MD, PhD
Organizational Affiliation
Institut Gustave Roussy, Villejuif, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yungan Tao, MD
Organizational Affiliation
Institut Gustave Roussy, Villejuif, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denis BARRITAULT, PhD
Organizational Affiliation
Organ, Tissue, Regeneration, Repair and Replacement
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
State/Province
Ile de France
ZIP/Postal Code
94010
Country
France
Facility Name
APHP - Hôpital Tenon
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75970
Country
France
Facility Name
Institut de Cancérologie Gustave Roussy
City
Villejuif
State/Province
Ile de France
ZIP/Postal Code
94800
Country
France
Facility Name
Centre de Cancérologie Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CHRU de Besançon, Site du CH Belfort-Montbéliard
City
Montbéliard
ZIP/Postal Code
25200
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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