INEC Study: Immuno-modulating Enteral Nutrition in Cancer
This study has been completed.
Sponsor:
University Hospital, Clermont-Ferrand
Collaborators:
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
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00333099
First received: June 1, 2006
Last updated: September 13, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malnutrition Esophageal Cancer Head and Neck Cancer |
Dietary Supplement: Impact (R) Enteral Nutrition Other: impact |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Esophageal Cancer
Esophagus Disorders
Head and Neck Cancer
Malnutrition
U.S. FDA Resources
Further study details as provided by University Hospital, Clermont-Ferrand:
Primary Outcome Measures:
- Frequency and grade of mucositis [ Time Frame: each visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 250 |
| Study Start Date: | May 2006 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: nutrition
study of immuno-modulating enteral nutrition
|
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 |
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333099
Locations
| France | |
| Hotel Dieu | |
| Clermont-Ferrand, Auvergne, France, 63058 | |
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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
Investigators
| Principal Investigator: | Corinne Bouteloup, Doctor | Hotel Dieu Service d'Hepato-Gastro-Enterologie (service du Pr G. Bommelaer) Clermont-Ferrand |
| Study Director: | Marie-Paule Vasson, Professor | CLAN, Unité de Nutrition, Centre Jean Perrin (Clermont-Ferrand) |
More Information
Additional Information:
Publications:
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT00333099 History of Changes |
| Other Study ID Numbers: | CHU63-0012 |
| Study First Received: | June 1, 2006 |
| Last Updated: | September 13, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Enteral nutrition immunonutrients head and neck cancer |
esophageal cancer chemoradiotherapy H&N or esophageal cancer patients with a chemoradiotherapy treatment. |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Head and Neck Neoplasms Malnutrition Gastrointestinal Diseases Digestive System Diseases |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Nutrition Disorders |
ClinicalTrials.gov processed this record on May 21, 2013