INEC Study: Immuno-modulating Enteral Nutrition in Cancer

This study has been completed.
Sponsor:
Collaborators:
Fonds National d'Aménagement et de Développement du territoire (FNADT)
Fonds Européens de développement Régional (FEDER)
Centre Jean Perrin
Centre Leon Berard
Institut de Cancérologie de la Loire, Saint-Etienne (France)
Centre Hospitalier Universitaire de Saint Etienne
Hôpital Edouard Herriot
University Hospital, Grenoble
ORKYN, home medical care (France)
Novartis
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00333099
First received: June 1, 2006
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Malnutrition
Esophageal Cancer
Head and Neck Cancer
Dietary Supplement: Impact (R) Enteral Nutrition
Other: impact
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Frequency and grade of mucositis [ Time Frame: each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect on treatment conditions (interruption, doses) [ Time Frame: each visit ] [ Designated as safety issue: No ]
  • Other complications linked to chemoradiotherapy [ Time Frame: each week of chemoradiotherapy ] [ Designated as safety issue: No ]
  • Nutritional and immune status [ Time Frame: at randomisation's visit, visit at the end of treatment, 1, 6 and 12 months after the end of treatment ] [ Designated as safety issue: No ]
  • Life quality [ Time Frame: at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment ] [ Designated as safety issue: No ]
  • Cost [ Time Frame: each visit ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: May 2006
Study Completion Date: September 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: nutrition
study of immuno-modulating enteral nutrition
Dietary Supplement: Impact (R) Enteral Nutrition
mucositis frequency, treatment tolerance
Other: impact

1500 calories every day :

-5 days before the begining of the chemoradiotherapy and until the last day of the treatment


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 µmol/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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333099

Locations
France
Hotel Dieu
Clermont-Ferrand, Auvergne, France, 63058
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Fonds National d'Aménagement et de Développement du territoire (FNADT)
Fonds Européens de développement Régional (FEDER)
Centre Jean Perrin
Centre Leon Berard
Institut de Cancérologie de la Loire, Saint-Etienne (France)
Centre Hospitalier Universitaire de Saint Etienne
Hôpital Edouard Herriot
University Hospital, Grenoble
ORKYN, home medical care (France)
Novartis
Investigators
Principal Investigator: Corinne Bouteloup, Doctor Hotel Dieu Service d'Hepato-Gastro-Enterologie (service du Pr G. Bommelaer) Clermont-Ferrand
Study Director: Marie-Paule Vasson, Professor CLAN, Unité de Nutrition, Centre Jean Perrin (Clermont-Ferrand)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00333099     History of Changes
Other Study ID Numbers: CHU63-0012
Study First Received: June 1, 2006
Last Updated: September 13, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Enteral nutrition
immunonutrients
head and neck cancer
esophageal cancer
chemoradiotherapy
H&N or esophageal cancer patients with a chemoradiotherapy treatment.

Additional relevant MeSH terms:
Esophageal Neoplasms
Head and Neck Neoplasms
Malnutrition
Nutrition Disorders
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2014