Status:
COMPLETED
Study of Nutrition Regimens in Treating Patients With Cancer of the Upper Aerodigestive Tract
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Head and Neck Cancer
Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
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 treatmen...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT00765440
Start Date
July 1 2007
End Date
April 1 2011
Last Update
September 30 2025
Active Locations (1)
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1
Centre Antoine Lacassagne
Nice, France, 06189