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

Primary Purpose

Head and Neck Cancer, Infection, Malnutrition

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
therapeutic nutritional supplementation
placebo
Sponsored by
Centre Antoine Lacassagne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Antoine Lacassagne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm Description

Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery.

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.

Patients receive oral or enteral IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant IMPACT® nutrition over 7 days after surgery.

Outcomes

Primary Outcome Measures

Rate of infectious complication

Secondary Outcome Measures

Full Information

First Posted
October 2, 2008
Last Updated
February 8, 2015
Sponsor
Centre Antoine Lacassagne
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1. Study Identification

Unique Protocol Identification Number
NCT00765440
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Placebo Comparator
Arm Description
Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
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 Title
Arm III
Arm Type
Experimental
Arm Description
Patients receive oral or enteral IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant IMPACT® nutrition over 7 days after surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
therapeutic nutritional supplementation
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Rate of infectious complication
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Noelle Falewee Pastor
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24182765
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.
Results Reference
derived

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

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