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

NCT ID: NCT01149642

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2014-12-31

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.

Conditions

Severe Acute Mucositis; Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral Impact

Intervention Type: DIETARY_SUPPLEMENT

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

The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GORTEC

OTHER

Sponsor Role: collaborator

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32936874 (View on PubMed)

Other Identifiers

VA2009/13

Identifier Type: OTHER

Identifier Source: secondary_id

IMPATOX

Identifier Type: -

Identifier Source: org_study_id