Study of Nutrition Regimens in Treating Patients With Cancer of the Upper Aerodigestive Tract (NCT00765440) | Clinical Trial Compass
CompletedPhase 3
Study of Nutrition Regimens in Treating Patients With Cancer of the Upper Aerodigestive Tract
France311 participantsStarted 2007-07
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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