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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT00765440
First received: October 2, 2008
Last updated: February 8, 2015
Last verified: February 2015
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • Rate of infectious complication [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 311
Study Start Date: July 2007
Study Completion Date: April 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765440

Locations
France
Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Study Chair: Marie-Noelle Falewee Pastor Centre Antoine Lacassagne
  More Information

Additional Information:
No publications provided by Centre Antoine Lacassagne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT00765440     History of Changes
Other Study ID Numbers: CDR0000599477
Study First Received: October 2, 2008
Last Updated: February 8, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Antoine Lacassagne:
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
Neoplasms by Site
Nutrition Disorders

ClinicalTrials.gov processed this record on September 02, 2015