Study of Nutrition Regimens in Treating Patients With Can... | NCT00765440 | Trialant
NCT00765440
Sponsor
Centre Antoine Lacassagne
Status
Completed
Last Update Posted
Sep 30, 2025Actual
Enrollment
311Actual
Phase
Phase 3
Conditions
Head and Neck Cancer
Infection
Malnutrition
Interventions
therapeutic nutritional supplementation
placebo
Countries
France
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00765440
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2006/26
Secondary IDs
ID
Type
Description
Link
2007-A00091-52
Other Identifier
AFSSAPS ID RCP
Brief Title
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
Acronym
Not provided
Organization
Centre Antoine LacassagneOTHER
Status Module
Record Verification Date
Feb 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2007
Primary Completion Date
Jul 2009Actual
Completion Date
Apr 2011Actual
First Submitted Date
Oct 2, 2008
First Submission Date that Met QC Criteria
Oct 2, 2008
First Posted Date
Oct 3, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 29, 2025
Last Update Posted Date
Sep 30, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Centre Antoine LacassagneOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
311Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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.
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
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D006258
Head and Neck Neoplasms
D007239
Infections
D044342
Malnutrition
D000077195
Squamous Cell Carcinoma of Head and Neck
D014062
Tongue Neoplasms
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D009748
Nutrition Disorders
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
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