- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00765440
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06189
- Centre Antoine Lacassagne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Arm I
Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery.
|
Given orally
|
Experimental: 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.
|
Given orally
Given orally
|
Experimental: 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.
|
Given orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of infectious complication
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Marie-Noelle Falewee Pastor, Centre Antoine Lacassagne
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III verrucous carcinoma of the oral cavity
- stage III mucoepidermoid carcinoma of the oral cavity
- stage III adenoid cystic carcinoma of the oral cavity
- stage IV verrucous carcinoma of the oral cavity
- stage IV mucoepidermoid carcinoma of the oral cavity
- stage IV adenoid cystic carcinoma of the oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage III lymphoepithelioma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage IV lymphoepithelioma of the oropharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- 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
- infection
- malnutrition
- stage I squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the larynx
- stage I squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the oropharynx
- tongue cancer
- stage I verrucous carcinoma of the oral cavity
- stage II verrucous carcinoma of the oral cavity
- stage I verrucous carcinoma of the larynx
- stage II verrucous carcinoma of the larynx
- stage I adenoid cystic carcinoma of the oral cavity
- stage I mucoepidermoid carcinoma of the oral cavity
- stage II adenoid cystic carcinoma of the oral cavity
- stage II mucoepidermoid carcinoma of the oral cavity
- stage I lymphoepithelioma of the oropharynx
- stage II lymphoepithelioma of the oropharynx
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000599477
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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