INEC Study: Immuno-modulating Enteral Nutrition in Cancer

September 13, 2012 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63058
        • Hotel Dieu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and grade of mucositis
Time Frame: each visit
each visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect on treatment conditions (interruption, doses)
Time Frame: each visit
each visit
Other complications linked to chemoradiotherapy
Time Frame: each week of chemoradiotherapy
each week of chemoradiotherapy
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
at randomisation's visit, visit at the end of treatment, 1, 6 and 12 months after the end of treatment
Life quality
Time Frame: at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment
at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment
Cost
Time Frame: each visit
each visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Centre Leon Berard
Novartis
Centre Hospitalier Universitaire de Saint Etienne
Institut de Cancérologie de la Loire
Centre Jean Perrin
University Hospital, Grenoble
Hôpital Edouard Herriot
Orkyn'
European Regional Development Fund
Fonds National d'Aménagement et de Développement du territoire (FNADT)

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 1, 2006

First Submitted That Met QC Criteria

June 1, 2006

First Posted (Estimate)

June 2, 2006

Study Record Updates

Last Update Posted (Estimate)

September 14, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU63-0012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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