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

Head and Neck Cancer Clinical Trial

Official title:

Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765440
• Other study ID #: CDR0000599477
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2008
• Last updated: February 8, 2015
• Start date: July 2007
• Est. completion date: April 2011

Study information

• Verified date: February 2015
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: April 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Infection
• Malnutrition

Intervention

Dietary Supplement:
• therapeutic nutritional supplementation
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of infectious complication		1 year	No