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

NCT ID: NCT00765440

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-04-30

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.

Conditions

Head and Neck Cancer; Infection; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Arm I

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally

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.

Group Type: EXPERIMENTAL

therapeutic nutritional supplementation

Intervention Type: DIETARY_SUPPLEMENT

Given orally

placebo

Intervention Type: OTHER

Given orally

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.

Group Type: EXPERIMENTAL

therapeutic nutritional supplementation

Intervention Type: DIETARY_SUPPLEMENT

Given orally

Interventions

therapeutic nutritional supplementation

Given orally

Intervention Type: DIETARY_SUPPLEMENT

placebo

Given orally

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of de novo cancer of the upper aerodigestive tract, including the following:

• Oral cavity
• Larynx
• Oropharynx
• Hypopharynx
• Planned surgical excision of tumors with opening of the mucous membranes, with or without immediate reconstruction by myocutaneous pedicle flap or free-bone graft
• Planned adjuvant enteral nutritional regimen lasting at least 7 days post-operatively

PATIENT CHARACTERISTICS:

• ANC > 1.8 x 10^9/L
• Hemoglobin > 9 g/dL
• Transaminases ≤ 3 times upper limit of normal (ULN)
• Bilirubin ≤ 3 times ULN
• Creatinine 70-250 μmol/L
• Urea ≤ 1.5 times ULN
• Glucose < 1.5 g/L
• Sodium < 145 mmol/L
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No psychological, social, geographical, or familial reasons prohibiting follow-up
• No insulin-dependent diabetes
• No severe psychiatric illness

PRIOR CONCURRENT THERAPY:

• No head and neck surgery for cancer within the past year
• No prior oral components of immunonutrition
• No prior neoadjuvant chemotherapy
• No prior radiotherapy to head and neck

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

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Noelle Falewee Pastor

Role: STUDY_CHAIR

Centre Antoine Lacassagne

Locations

Centre Antoine Lacassagne

Nice, , France

Countries

France

References

Falewee MN, Schilf A, Boufflers E, Cartier C, Bachmann P, Pressoir M, Banal A, Michel C, Ettaiche M. Reduced infections with perioperative immunonutrition in head and neck cancer: exploratory results of a multicenter, prospective, randomized, double-blind study. Clin Nutr. 2014 Oct;33(5):776-84. doi: 10.1016/j.clnu.2013.10.006. Epub 2013 Oct 17.

Reference Type: DERIVED

PMID: 24182765 (View on PubMed)

Other Identifiers

2007-A00091-52

Identifier Type: OTHER

Identifier Source: secondary_id

2006/26

Identifier Type: -

Identifier Source: org_study_id