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Completed

NCT Number: NCT01840436

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Intercommunal de Créteil, Créteil, Île-de-France Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MUCIPLIQ

Device

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

PLACEBO

Device

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

Primary outcomes

  1. Incidence of grade 2 or higher oral mucositis

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

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

Secondary outcomes

  1. Number and Terms of grade 2 or higher oral mucositis

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

    Differences of number and terms of oral mucositis of grade 2 or higher between MUCIPLIQ and placebo groups

  2. Administered-antalgics posology and nature

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

    Differences of administered-antalgics posology and nature between MUCIPLIQ and placebo groups

  3. Pain experienced in time

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

    Differences of pain experienced by patients between MUCIPLIQ and placebo groups, assessed with Numerical Pain Scale (0 to 10).

  4. Assessment of the Oral Health Impact Profile

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

    Assessment of the Oral Health Impact Profile assessed by the OHIP-14 questionnaire between MUCIPLIQ and placebo groups

  5. Weight curve

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

    Assessment of the weight curves for MUCIPLIQ and placebo groups

Sponsors and collaborators

Lead sponsor

Organ, Tissue, Regeneration, Repair and Replacement

Industry

Registry information

Official study 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

Acronym: MUCIPLIQ

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2013
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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