Study of Nutrition Regimens in Treating Patients With Cancer of the Upper Aerodigestive Tract
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Centre Antoine Lacassagne
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00765440
First received: October 2, 2008
Last updated: February 24, 2011
Last verified: July 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Infection Malnutrition |
Dietary Supplement: therapeutic nutritional supplementation Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Dietary Supplements
Head and Neck Cancer
Malnutrition
Tonsils and Adenoids
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Rate of infectious complication [ Designated as safety issue: No ]
| Estimated Enrollment: | 420 |
| Study Start Date: | July 2007 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: placebo
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.
|
Dietary Supplement: therapeutic nutritional supplementation
Given orally
Other: placebo
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.
|
Dietary Supplement: therapeutic nutritional supplementation
Given orally
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765440
Locations
| France | |
| Centre Antoine Lacassagne | Recruiting |
| Nice, France, 06189 | |
| Contact: Marie-Noelle Falewee Pastor 33-49-203-1000 | |
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
| Study Chair: | Marie-Noelle Falewee Pastor | Centre Antoine Lacassagne |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00765440 History of Changes |
| Other Study ID Numbers: | CDR0000599477, CALACASS-IMPACT, CALACASS-2006/26, INCA-RECF0619, EUDRACT-2007-A00091-52, NOVARTIS-CALACASS-IMPACT, NESTLE-CALACASS-IMPACT |
| Study First Received: | October 2, 2008 |
| Last Updated: | February 24, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Malnutrition Neoplasms by Site Neoplasms Nutrition Disorders |
ClinicalTrials.gov processed this record on May 16, 2013