INEC Study: Immuno-modulating Enteral Nutrition in Cancer
NCT ID: NCT00333099
Last Updated: 2012-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
250 participants
INTERVENTIONAL
2006-05-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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nutrition
study of immuno-modulating enteral nutrition
Impact (R) Enteral Nutrition
mucositis frequency, treatment tolerance
impact
1500 calories every day :
-5 days before the begining of the chemoradiotherapy and until the last day of the treatment
Interventions
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Impact (R) Enteral Nutrition
mucositis frequency, treatment tolerance
impact
1500 calories every day :
-5 days before the begining of the chemoradiotherapy and until the last day of the treatment
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Fonds National d'Aménagement et de Développement du territoire (FNADT)
UNKNOWN
European Regional Development Fund
OTHER
Centre Jean Perrin
OTHER
Centre Leon Berard
OTHER
Institut de Cancérologie de la Loire
OTHER
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Hôpital Edouard Herriot
OTHER
University Hospital, Grenoble
OTHER
Orkyn'
INDUSTRY
Novartis
INDUSTRY
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Corinne Bouteloup, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hotel Dieu Service d'Hepato-Gastro-Enterologie (service du Pr G. Bommelaer) Clermont-Ferrand
Marie-Paule Vasson, Professor
Role: STUDY_DIRECTOR
CLAN, Unité de Nutrition, Centre Jean Perrin (Clermont-Ferrand)
Locations
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Hotel Dieu
Clermont-Ferrand, Auvergne, France
Countries
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References
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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. doi: 10.1053/ejso.2002.1257.
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. doi: 10.1053/gast.2002.33587.
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. doi: 10.1038/sj.ejcn.1602034.
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.
Related Links
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Related Info
Other Identifiers
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CHU63-0012
Identifier Type: -
Identifier Source: org_study_id