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

O

Organ, Tissue, Regeneration, Repair and Replacement

Status

Completed

Conditions

Carcinoma in Situ of Upper Respiratory Tract
Oral Mucositis

Treatments

Device: Placebo
Device: MUCIPLIQ

Study type

Interventional

Funder types

Industry

Identifiers

NCT01840436
CT11M10MURT

Details and patient eligibility

About

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.

Enrollment

136 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

136 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
This arm receives a placebo (saline solution) mouthwash treatment twice a day.
Treatment:
Device: Placebo
MUCIPLIQ 0.05 mg/mL
Experimental group
Description:
This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day.
Treatment:
Device: MUCIPLIQ
MUCIPLIQ 0.015 mg/mL
Experimental group
Description:
This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day.
Treatment:
Device: MUCIPLIQ

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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