Clinical trial · Interventional
INEC Study: Immuno-modulating Enteral Nutrition in Cancer
Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer
NCT00333099CI-TRIAL-00120217completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| impact | Other | — | UNRESOLVED |
| Impact (R) Enteral Nutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- PLACEBO_COMPARATOR
- label
- nutrition
- description
- study of immuno-modulating enteral nutrition
- interventionNames
- Dietary Supplement: Impact (R) Enteral Nutrition
- Other: impact
Primary outcomes (1)
- measure
- Frequency and grade of mucositis
- timeFrame
- each visit
Secondary outcomes (5)
- measure
- Effect on treatment conditions (interruption, doses)
- timeFrame
- each visit
- measure
- Other complications linked to chemoradiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDVasson 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. PMID 23849811
- BACKGROUNDvan 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. PMID 10430262
- BACKGROUNDNozoe 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. PMID 12099649
- BACKGROUNDGianotti 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. PMID 12055582
- BACKGROUNDde 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. PMID 15266308
- DERIVEDTalvas 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.