Clinical trial NCT00333099: INEC Study: Immuno-modulating Enteral Nutrition in Cancer
Official title: Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Esophageal Cancer
Head and Neck Cancer
Keywords: Enteral nutrition
immunonutrients
head and neck cancer
esophageal cancer
chemoradiotherapy
H&N or esophageal cancer patients with a chemoradiotherapy treatment.
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Fonds National d'Aménagement et de Développement du territoire (FNADT)
name: European Regional Development Fund
name: Centre Jean Perrin
name: Centre Leon Berard
name: Institut de Cancérologie de la Loire
name: Centre Hospitalier Universitaire de Saint Etienne
name: Hôpital Edouard Herriot
name: University Hospital, Grenoble
name: Orkyn'
name: Novartis
First posted: 2006-06-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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.

Primary outcomes:
measure: Frequency and grade of mucositis
timeFrame: each visit
Secondary outcomes:
measure: Effect on treatment conditions (interruption, doses)
timeFrame: each visit
measure: Other complications linked to chemoradiotherapy
timeFrame: each week of chemoradiotherapy
measure: Nutritional and immune status
timeFrame: at randomisation's visit, visit at the end of treatment, 1, 6 and 12 months after the end of treatment
measure: Life quality
timeFrame: at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment
measure: Cost
timeFrame: each visit
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Hotel Dieu
state: Auvergne
Study officials:
affiliation: Hotel Dieu Service d'Hepato-Gastro-Enterologie (service du Pr G. Bommelaer) Clermont-Ferrand
name: Corinne Bouteloup, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CLAN, Unité de Nutrition, Centre Jean Perrin (Clermont-Ferrand)
name: Marie-Paule Vasson, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.