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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

June 1, 2006
September 13, 2012
May 2006
September 2010   (final data collection date for primary outcome measure)
Frequency and grade of mucositis [ Time Frame: each visit ] [ Designated as safety issue: No ]
Frequency and grade of mucositis
Complete list of historical versions of study NCT00333099 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Effect on treatment conditions (interruption, doses, decrease...)
  • Other complication linked to chemoradiotherapy
  • Nutritional and immune status
  • Life quality
  • Cost
Not Provided
Not Provided
 
INEC Study: Immuno-modulating Enteral Nutrition in Cancer
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Malnutrition
  • Esophageal Cancer
  • Head and Neck Cancer
  • 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

Placebo Comparator: nutrition
study of immuno-modulating enteral nutrition
Interventions:
  • Dietary Supplement: Impact (R) Enteral Nutrition
  • Other: impact

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
September 2011
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00333099
CHU63-0012
Not Provided
University Hospital, Clermont-Ferrand
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
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)
University Hospital, Clermont-Ferrand
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP