INEC Study: Immuno-modulating Enteral Nutrition in Cancer

Head and Neck Cancer Clinical Trial

Official title:

Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333099
• Other study ID #: CHU63-0012
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2006
• Last updated: September 13, 2012
• Start date: May 2006
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Malnutrition

Intervention

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

Locations

Country	Name	City	State
France	Hotel Dieu	Clermont-Ferrand	Auvergne

Sponsors (11)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Centre Hospitalier Universitaire de Saint Etienne, Centre Jean Perrin, Centre Leon Berard, Fonds Européens de développement Régional (FEDER), Fonds National d'Aménagement et de Développement du territoire (FNADT), Hôpital Edouard Herriot, Institut de Cancérologie de la Loire, Novartis, ORKYN, home medical care (France), University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and grade of mucositis		each visit	No
Secondary	Effect on treatment conditions (interruption, doses)		each visit	No
Secondary	Other complications linked to chemoradiotherapy		each week of chemoradiotherapy	No
Secondary	Nutritional and immune status		at randomisation's visit, visit at the end of treatment, 1, 6 and 12 months after the end of treatment	No
Secondary	Life quality		at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment	No
Secondary	Cost		each visit	No

External Links

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