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

NCT00765440 | Completed Phase 3

• 2 other identifiers: 2006/262007-A00091-52
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

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 randomized phase III trial is comparing three nutrition regimens in treating patients with cancer of the upper aerodigestive tract.

Conditions

Head and Neck Cancer; Infection; Malnutrition

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

Outcome Measures

Primary Outcomes (1)

• Rate of infectious complication

  1 year

Study Arms (3)

Arm I

PLACEBO COMPARATOR

Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery.

Other: placebo

Arm II

EXPERIMENTAL

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; Other: placebo

Arm III

EXPERIMENTAL

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

Interventions

therapeutic nutritional supplementation DIETARY_SUPPLEMENT

Given orally

Arm II; Arm III

placebo OTHER

Given orally

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

• Falewee 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Infections; Malnutrition; Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Nutrition Disorders; Nutritional and Metabolic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Study Officials

• Marie-Noelle Falewee Pastor

  Centre Antoine Lacassagne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: April 1, 2011
• Last Updated: September 30, 2025

Record last verified: 2015-02

Locations

FR (1)