INEC Study: Immuno-modulating Enteral Nutrition in Cancer

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ClinicalTrials.gov Identifier: NCT00333099

Recruitment Status : Completed

First Posted : June 2, 2006

Last Update Posted : September 14, 2012

Sponsor:

Collaborators:

Fonds National d'Aménagement et de Développement du territoire (FNADT)

European Regional Development Fund

Centre Jean Perrin

Centre Leon Berard

Institut de Cancérologie de la Loire

Centre Hospitalier Universitaire de Saint Etienne

Hôpital Edouard Herriot

University Hospital, Grenoble

Orkyn'

Novartis

Information provided by (Responsible Party):

University Hospital, Clermont-Ferrand

Study Description

Brief Summary:

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

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	250 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Official Title:	Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer
Study Start Date :	May 2006
Actual Primary Completion Date :	September 2010
Actual Study Completion Date :	September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Esophageal Cancer

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Frequency and grade of mucositis [ Time Frame: each visit ]

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333099

Locations

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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)

European Regional Development Fund

Centre Jean Perrin

Centre Leon Berard

Institut de Cancérologie de la Loire

Centre Hospitalier Universitaire de Saint Etienne

Hôpital Edouard Herriot

University Hospital, Grenoble

Orkyn'

Novartis

Investigators

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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

Publications:

van Bokhorst-de van der Schuer, van Leeuwen PA, Kuik DJ, Klop WM, Sauerwein HP, Snow GB, Quak JJ. The impact of nutritional status on the prognoses of patients with advanced head and neck cancer. Cancer. 1999 Aug 1;86(3):519-27.

Nozoe T, Kimura Y, Ishida M, Saeki H, Korenaga D, Sugimachi K. Correlation of pre-operative nutritional condition with post-operative complications in surgical treatment for oesophageal carcinoma. Eur J Surg Oncol. 2002 Jun;28(4):396-400.

Gianotti L, Braga M, Nespoli L, Radaelli G, Beneduce A, Di Carlo V. A randomized controlled trial of preoperative oral supplementation with a specialized diet in patients with gastrointestinal cancer. Gastroenterology. 2002 Jun;122(7):1763-70.

de Luis DA, Arranz M, Aller R, Izaola O, Cuellar L, Terroba MC. Immunoenhanced enteral nutrition, effect on inflammatory markers in head and neck cancer patients. Eur J Clin Nutr. 2005 Jan;59(1):145-7.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Talvas J, Garrait G, Goncalves-Mendes N, Rouanet J, Vergnaud-Gauduchon J, Kwiatkowski F, Bachmann P, Bouteloup C, Bienvenu J, Vasson MP. Immunonutrition stimulates immune functions and antioxidant defense capacities of leukocytes in radiochemotherapy-treated head & neck and esophageal cancer patients: A double-blind randomized clinical trial. Clin Nutr. 2015 Oct;34(5):810-7. doi: 10.1016/j.clnu.2014.12.002. Epub 2014 Dec 9.

Vasson MP, Talvas J, Perche O, Dillies AF, Bachmann P, Pezet D, Achim AC, Pommier P, Racadot S, Weber A, Ramdani M, Kwiatkowski F, Bouteloup C. Immunonutrition improves functional capacities in head and neck and esophageal cancer patients undergoing radiochemotherapy: a randomized clinical trial. Clin Nutr. 2014 Apr;33(2):204-10. doi: 10.1016/j.clnu.2013.06.008. Epub 2013 Jun 20.

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Responsible Party:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00333099 History of Changes
Other Study ID Numbers:	CHU63-0012
First Posted:	June 2, 2006 Key Record Dates
Last Update Posted:	September 14, 2012
Last Verified:	September 2012

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:

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Head and Neck Neoplasms Esophageal Neoplasms Malnutrition Neoplasms by Site Neoplasms Gastrointestinal Neoplasms	Digestive System Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nutrition Disorders

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