INEC Study: Immuno-modulating Enteral Nutrition in Cancer

• Effect on treatment conditions (interruption, doses) [ Time Frame: each visit ] [ Designated as safety issue: No ]
• Other complications linked to chemoradiotherapy [ Time Frame: each week of chemoradiotherapy ] [ Designated as safety issue: No ]
• Nutritional and immune status [ Time Frame: at randomisation's visit, visit at the end of treatment, 1, 6 and 12 months after the end of treatment ] [ Designated as safety issue: No ]
• Life quality [ Time Frame: at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment ] [ Designated as safety issue: No ]
• Cost [ Time Frame: each visit ] [ Designated as safety issue: No ]

• Effect on treatment conditions (interruption, doses, decrease...)
• Other complication linked to chemoradiotherapy
• Nutritional and immune status
• Life quality
• Cost

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.

• Malnutrition
• Esophageal Cancer
• Head and Neck Cancer

• 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

• 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.
• 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.
• 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.

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.

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