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


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Head and Neck Cancer, Infection, Malnutrition

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Rate of infectious complication

Safety Issue:

No

Principal Investigator

Marie-Noelle Falewee Pastor

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

Unspecified

Study ID:

CDR0000599477

NCT ID:

NCT00765440

Start Date:

July 2007

Completion Date:

Related Keywords:

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

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