Status:
COMPLETED
Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborating Sponsors:
GORTEC
Conditions:
Severe Acute Mucositis
Head and Neck Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and con...
Eligibility Criteria
Inclusion
- Epidermal carcinoma proven histologically of the sphere ORL (all locations except nasopharynx).
- Patients with tumours of the oral cavity, the oropharynx, the hypopharynx and the larynx treated initially by surgery and eligible for post-operative radio- chemotherapy concomitantly.
- NB. The patients with tumours of the larynx or hypopharynx are eligible if the radiotherapy to the oropharyngeal mucosa will be at least 54 Gy and the mucositis can be visualised without the use of instruments.
- Radio-chemotherapy to be given postoperatively.
- Maximum delay of 8 weeks between the operative date and the planned starting date of radio-chemotherapy.
- Performance status (grade OMS): 0, 1, 2
- Nutritional Risk Index ≥ 83.5
- No mucositis.
- Age: 18-75 years
- Life expectancy ≥ 3 months.
- Informed consent obtained from the patient.
- Affiliation with a social security system.
Exclusion
- Tumour of nasopharynx
- Mucositis
- Severe sepsis
- Treatment by immunomodulators in the month preceding inclusion
- ATCD allergy to the components of Oral Impact.
- Parenteral nutrition at inclusion
- Usual contraindications to concomitant radio-chemotherapy
- Patient already included in another therapeutic trial involving an experimental molecule
- Female pregnant or susceptible to being pregnant, or breast-feeding. Patient not using appropriate contraceptive measures during the treatment
- Persons deprived of liberty or under guardianship
- Patients unable to commit to the trial schedule for geographical, social or psychological reasons.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01149642
Start Date
November 1 2009
End Date
December 1 2014
Last Update
August 13 2020
Active Locations (1)
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1
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, France, 34298