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Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer


Phase 4
18 Years
N/A
Not Enrolling
Both
Malnutrition, Esophageal Cancer, Head and Neck Cancer

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Trial Information

Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer


Malnutrition is frequent in head and neck (H&N) and esophageal cancers and alters immune
status, anti-infectious and anti-tumoral defenses and the response to the treatment
(surgery, chemotherapy, radiotherapy). Treatment of these 2 types of cancer is often
chemoradiotherapy which frequently induces mucositis. Mucositis enhances nutritional risk
and could impose a modification or an interruption of the treatment. The aim of this study
is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients,
using an arginine, omega 3 fatty acid, nucleotides-enhanced diet [Impact(R), Novartis]
versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes
(mucositis frequency, treatment tolerance), nutritional and immune status, and life quality
parameters.


Inclusion Criteria:



- H&N and esophageal cancer patients, not treated by surgery and needing
chemoradiotherapy

- Performance status: Objective Mucositis Score (OMS) of 0, 1, 2 or Karnofsky > 50%

- Acceptance of a gastrostomy, jejunostomy or a nasogastric tube to conduct enteral
nutrition

- Informed consent form signed

Exclusion Criteria:

- H&N cancer treated by exclusive radiotherapy

- H&N and esophageal cancer which can be treated by exclusive surgery

- Tonsil cancer

- Existence of metastases

- Concomitant cancer

- Repeat of cancer at site

- Insulin dependant diabetes

- Thyroid diseases

- Subjects with major surgery or severe infectious status in the 3 preceding months

- Biological assessment incompatible with the esophagus chemotherapy treatment
(polynuclear cells < 1500/ml; blood platelets < 100000/ml; serum creatinine > 130
┬Ámol/ml; ASAT, ALAT, ALP and bilirubin > twice the norm)

- Patients taking food or supplements enriched with omega 3 (arginine and nucleotides),
during the period of the study and in the preceding month

- Breast feeding women or in period of fertility without effective means of
contraception

- Patients who refuse to participate or are unable to receive information or are unable
to sign written informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Outcome Measure:

Frequency and grade of mucositis

Outcome Time Frame:

each visit

Safety Issue:

No

Principal Investigator

Corinne Bouteloup, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hotel Dieu Service d'Hepato-Gastro-Enterologie (service du Pr G. Bommelaer) Clermont-Ferrand

Authority:

France: Ministry of Health

Study ID:

CHU63-0012

NCT ID:

NCT00333099

Start Date:

May 2006

Completion Date:

September 2011

Related Keywords:

  • Malnutrition
  • Esophageal Cancer
  • Head and Neck Cancer
  • Enteral nutrition
  • immunonutrients
  • head and neck cancer
  • esophageal cancer
  • chemoradiotherapy
  • H&N or esophageal cancer patients with a chemoradiotherapy treatment.
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Malnutrition

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