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

Centre Antoine Lacassagne311 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

311

Conditions

Head and Neck Cancer Infection Malnutrition

Interventions

therapeutic nutritional supplementationDIETARY_SUPPLEMENT

Given orally

placeboOTHER

Given orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Antoine Lacassagne

Nice, France

Outcomes

Primary Outcomes

Rate of infectious complication

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.