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

Centre Antoine Lacassagne

Status and phase: Completed; Phase 3

Conditions: Infection; Malnutrition; Head and Neck Cancer

Treatments: Other: placebo; Dietary Supplement: therapeutic nutritional supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT00765440

2006/26

2007-A00091-52 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 311 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

311 participants in 3 patient groups, including a placebo group

Arm I

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

Arm II

Experimental group

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.

Treatment:

Dietary Supplement: therapeutic nutritional supplementation

Other: placebo

Arm III

Experimental group

Description:

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

Treatment:

Dietary Supplement: therapeutic nutritional supplementation