Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer (IMPATOX)

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Severe Acute Mucositis
• Intervention / Treatment: Dietary supplement: Oral Impact; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34298
    • Institut du Cancer de Montpellier - Val d'Aurelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oral immunomodulatory solution; The oral supplement is a 74g sachet containing 302 kcal and 16.7g proteins as well as immunonutrients such as L-Arginine, ARN and omega-3.	Dietary supplement: Oral Impact; The patients will benefit in each case from a similar energy supplement (either Oral Impact or placebo) during the 5 days preceding the course of chemotherapy. They will receive the supplement 3 times per day at 10am, 3pm and 5pm outside of their meals. In total, the patients will take the supplements for 15 days (3 courses of 5 days). If the patient has difficulty taking the treatment orally, it can be given via an enteral tube (nasogastric tube or percutaneous gastrostomy). All patients in the protocol will systematically receive a dietetic consultation. This consultation by a dietician will detect malnutrition and result in nutritional counsel if necessary (advice re. enrichment of diet, CNO without immunonutrients, artificial nutrition). Follow-up appointments with a dietician will be organised every 3 weeks to maintain adherence to the suggested dietary changes.
PLACEBO_COMPARATOR: Placebo; The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.	Dietary supplement: Placebo; The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of grade 3 and 4 acute mucosal toxicity	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance	tolerance of treatment with the CTCAE (Common Terminology Criteria for Adverse Events)	through study completion, an average of 3 years
compliance to the oral immunomodulating formula		through study completion, an average of 3 years
overall quality of life (EORTC QLQ-C30 Questionnaire)		through study completion, an average of 3 years
progression-free survival rates		1, 2 and 3 years
overall survival rates		1, 2 and 3 years

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Collaborators: GORTEC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: June 22, 2010
• First Posted (ESTIMATE): June 23, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mucositis
• Other Study ID Numbers: IMPATOX; VA2009/13 (OTHER: CRLC Val d'Aurelle-Paul Lamarque)