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

NCT01149642 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-08-13

No results posted yet for this study

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

Interventions

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.

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • GORTEC

    collaborator OTHER

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01149642 on ClinicalTrials.gov