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| Name | Class |
|---|---|
| Fonds National d'Aménagement et de Développement du territoire (FNADT) | UNKNOWN |
| European Regional Development Fund | OTHER |
| Centre Jean Perrin | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nutrition | Placebo Comparator | study of immuno-modulating enteral nutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impact (R) Enteral Nutrition | Dietary Supplement | mucositis frequency, treatment tolerance |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and grade of mucositis | each visit |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on treatment conditions (interruption, doses) | each visit | |
| Other complications linked to chemoradiotherapy | each week of chemoradiotherapy | |
| Nutritional and immune status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinne Bouteloup, Doctor | Hotel Dieu Service d'Hepato-Gastro-Enterologie (service du Pr G. Bommelaer) Clermont-Ferrand | Principal Investigator |
| Marie-Paule Vasson, Professor | CLAN, Unité de Nutrition, Centre Jean Perrin (Clermont-Ferrand) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu | Clermont-Ferrand | Auvergne | 63058 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10430262 | Background | 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. | |
| 12099649 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D004938 | Esophageal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| Centre Leon Berard |
| OTHER |
| Institut de Cancérologie de la Loire | OTHER |
| Centre Hospitalier Universitaire de Saint Etienne | OTHER |
| HĂ´pital Edouard Herriot | OTHER |
| University Hospital, Grenoble | OTHER |
| Orkyn' | INDUSTRY |
| Novartis | INDUSTRY |
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| impact |
| Other |
1500 calories every day : -5 days before the begining of the chemoradiotherapy and until the last day of the treatment |
|
| at randomisation's visit, visit at the end of treatment, 1, 6 and 12 months after the end of treatment |
| Life quality | at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment |
| Cost | each visit |
| 12055582 | Background | 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. |
| 15266308 | Background | 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. |
| 25575640 | Derived | 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. |
| 23849811 | Derived | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |