Clinical trial NCT01149642: Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer
Official title: Phase III Multicenter, Randomised and Double-blind Study Comparing an Oral Immunomodulatory Solution Versus a Placebo in Preventing Severe Acute Mucositis in Head and Neck Cancer Patients Treated Surgically and Concomitantly With Radiochemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Acute Mucositis
Head and Neck Cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
Collaborators: name: GORTEC
First posted: 2010-06-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The rate of grade 3 and 4 acute mucosal toxicity
timeFrame: 3 months
Secondary outcomes:
measure: Tolerance
timeFrame: through study completion, an average of 3 years
measure: compliance to the oral immunomodulating formula
timeFrame: through study completion, an average of 3 years
measure: overall quality of life (EORTC QLQ-C30 Questionnaire)
timeFrame: through study completion, an average of 3 years
measure: progression-free survival rates
timeFrame: 1, 2 and 3 years
measure: overall survival rates
timeFrame: 1, 2 and 3 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier - Val d'Aurelle
Study officials:
References:
citation: Boisselier P, Kaminsky MC, Thezenas S, Gallocher O, Lavau-Denes S, Garcia-Ramirez M, Alfonsi M, Cupissol D, de Forges H, Janiszewski C, Geoffrois L, Sire C, Senesse P; Head and Neck Oncology and Radiotherapy Group (GORTEC). A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX. Am J Clin Nutr. 2020 Dec 10;112(6):1523-1531. doi: 10.1093/ajcn/nqaa227.