Study of Nutrition Regimens in Treating Patients With Cancer of the Upper Aerodigestive Tract

Phase 3

Completed

• Conditions: Head and Neck Cancer; Infection; Malnutrition
• Interventions: Other: placebo; Dietary Supplement: therapeutic nutritional supplementation

• Registration Number: NCT00765440
• Lead Sponsor: Centre Antoine Lacassagne

Brief Summary

RATIONALE: It is not yet known which regimen of enteral nutrition is more effective in preventing infections in patients undergoing surgery for cancer of the upper aerodigestive tract.

PURPOSE: This randomized phase III trial is comparing three nutrition regimens in treating patients with cancer of the upper aerodigestive tract.

Detailed Description

OBJECTIVES:

Primary

* Determine the efficacy of immunonutrition (IMPACT®) in patients with de novo cancer of the upper aerodigestive tract.

Secondary

* Determine the best time to initiate treatment.

* Compare the intermediate duration of treatment.

* Compare nutritional parameters.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery.

* Arm II: Patients receive oral or enteral neoadjuvant IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant standard nutrition (IMPACT® placebo) over 7 days after surgery.

* Arm III: Patients receive oral or enteral IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant IMPACT® nutrition over 7 days after surgery.

After completion of study therapy, patients are followed at 30 days after surgery and then at 2 and 3 months.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2009-07
• Study Completion: 2011-04
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-08
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	placebo	Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery.
Arm II	placebo	Patients receive oral or enteral neoadjuvant IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant standard nutrition (IMPACT® placebo) over 7 days after surgery.
Arm III	therapeutic nutritional supplementation	Patients receive oral or enteral IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant IMPACT® nutrition over 7 days after surgery.
Arm II	therapeutic nutritional supplementation	Patients receive oral or enteral neoadjuvant IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant standard nutrition (IMPACT® placebo) over 7 days after surgery.

Primary Outcome Measures

Name	Time	Method
Rate of infectious complication	1 year

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France