Status:
COMPLETED
Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer
Lead Sponsor:
Organ, Tissue, Regeneration, Repair and Replacement
Conditions:
Oral Mucositis
Carcinoma in Situ of Upper Respiratory Tract
Eligibility:
All Genders
18+ years
Phase:
NA
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT01840436
Start Date
March 1 2013
End Date
January 1 2015
Last Update
May 5 2016
Active Locations (5)
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1
Centre de Cancérologie Léon Bérard
Lyon, France, 69373
2
CHRU de Besançon, Site du CH Belfort-Montbéliard
Montbéliard, France, 25200
3
Centre Hospitalier Intercommunal de Créteil
Créteil, Île-de-France Region, France, 94010
4
APHP - Hôpital Tenon
Paris, Île-de-France Region, France, 75970