Study of Nutrition Regimens in Treating Patients With Cancer of the Upper Aerodigestive Tract
Condition: Head and Neck Cancer; Infection; Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): therapeutic nutritional supplementation; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Given orally; Given orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: 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