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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract

Conditions
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Head and Neck Cancer, Infection, Malnutrition

Intervention / Treatment
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* Dietary Supplement: therapeutic nutritional supplementation
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm I<br>Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery. | Other: placebo<br>* Given orally<br>|
| Experimental: Arm II<br>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. | Dietary Supplement: therapeutic nutritional supplementation<br>* Given orally<br>Other: placebo<br>* Given orally<br>|
| Experimental: Arm III<br>Patients receive oral or enteral IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant IMPACT® nutrition over 7 days after surgery. | Dietary Supplement: therapeutic nutritional supplementation<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of infectious complication |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, malnutrition, stage I adenoid cystic carcinoma of the oral cavity, stage I mucoepidermoid carcinoma of the oral cavity, stage I verrucous carcinoma of the oral cavity, stage II adenoid cystic carcinoma of the oral cavity, stage II mucoepidermoid carcinoma of the oral cavity, stage II verrucous carcinoma of the oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, stage I lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, tongue cancer