Clinical trial · Interventional
Study of Nutrition Regimens in Treating Patients With Cancer of the Upper Aerodigestive Tract
Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract
NCT00765440CI-TRIAL-00095962completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Infection | — | UNRESOLVED | — |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| therapeutic nutritional supplementation | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Arm I
- description
- Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery.
- interventionNames
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm II
- description
- 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.
- interventionNames
- Dietary Supplement: therapeutic nutritional supplementation
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm III
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFalewee MN, Schilf A, Boufflers E, Cartier C, Bachmann P, Pressoir M, Banal A, Michel C, Ettaiche M. Reduced infections with perioperative immunonutrition in head and neck cancer: exploratory results of a multicenter, prospective, randomized, double-blind study. Clin Nutr. 2014 Oct;33(5):776-84. doi: 10.1016/j.clnu.2013.10.006. Epub 2013 Oct 17. PMID 24182765