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NCT Number: NCT00333099

INEC Study: Immuno-modulating Enteral Nutrition in Cancer

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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Key information

Conditions

Malnutrition Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu

Clermont-Ferrand, Auvergne, 63058, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Impact (R) Enteral Nutrition

Dietary Supplement

mucositis frequency, treatment tolerance

impact

Other

1500 calories every day :

-5 days before the begining of the chemoradiotherapy and until the last day of the treatment

Primary outcomes

  1. Frequency and grade of mucositis

    Time frame: each visit

Secondary outcomes

  1. Effect on treatment conditions (interruption, doses)

    Time frame: each visit

  2. Other complications linked to chemoradiotherapy

    Time frame: each week of chemoradiotherapy

  3. 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

  4. Life quality

    Time frame: at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment

  5. Cost

    Time frame: each visit

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne
  • Centre Jean Perrin
  • Centre Leon Berard
  • European Regional Development Fund
  • Fonds National d'Aménagement et de Développement du territoire (FNADT)
  • Hôpital Edouard Herriot
  • Institut de Cancérologie de la Loire
  • Novartis
  • Orkyn'
  • University Hospital, Grenoble

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Jun 2, 2006
Registry last updated
Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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