Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Open (Enrolling)
Both
Oral Mucositis, Carcinoma in Situ of Upper Respiratory Tract

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Incidence of grade 2 or higher oral mucositis

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Nicolas Daly-Schveitzer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Gustave Roussy, Villejuif, France

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

CT11M10MURT

NCT ID:

NCT01840436

Start Date:

March 2013

Completion Date:

June 2014

Related Keywords:

  • Oral Mucositis
  • Carcinoma in Situ of Upper Respiratory Tract
  • MUCIPLIQ
  • Matrix therapy
  • RGTA
  • Oral mucositis
  • Carcinoma
  • Carcinoma in Situ
  • Stomatitis
  • Mucositis
  • Stress, Psychological

Name

Location