Clinical trial NCT00765440: Study of Nutrition Regimens in Treating Patients With Cancer of the Upper Aerodigestive Tract
Official title: Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2008-10-03
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of infectious complication
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
affiliation: Centre Antoine Lacassagne
name: Marie-Noelle Falewee Pastor
role: STUDY_CHAIR
References:
citation: 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.