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

NCT01149642 | Completed

• 2 other identifiers: IMPATOXVA2009/13
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The rate of grade 3 and 4 acute mucosal toxicity

  3 months

Secondary Outcomes (5)

• Tolerance

  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

Study Arms (2)

Oral immunomodulatory solution

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Oral Impact 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.

Oral immunomodulatory solution

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Tumour of nasopharynx
• Mucositis
• Severe sepsis
• ATCD allergy to the components of Oral Impact.
• 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.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead
• GORTEC: collaborator

Study Sites (1)

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (1)

• 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.

  PMID: 32936874 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: November 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 13, 2020

Record last verified: 2018-12

Locations

FR (1)