INEC Study: Immuno-modulating Enteral Nutrition in Cancer
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ClinicalTrials.gov Identifier: NCT00333099 |
Recruitment Status :
Completed
First Posted : June 2, 2006
Last Update Posted : September 14, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malnutrition Esophageal Cancer Head and Neck Cancer | Dietary Supplement: Impact (R) Enteral Nutrition Other: impact | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Official Title: | Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: nutrition
study of immuno-modulating enteral nutrition
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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 |
- Frequency and grade of mucositis [ Time Frame: each visit ]
- Effect on treatment conditions (interruption, doses) [ Time Frame: each visit ]
- Other complications linked to chemoradiotherapy [ Time Frame: each week of chemoradiotherapy ]
- 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 ]
- Life quality [ Time Frame: at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment ]
- Cost [ Time Frame: each visit ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333099
France | |
Hotel Dieu | |
Clermont-Ferrand, Auvergne, France, 63058 |
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) |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital, Clermont-Ferrand |
ClinicalTrials.gov Identifier: | NCT00333099 History of Changes |
Other Study ID Numbers: |
CHU63-0012 |
First Posted: | June 2, 2006 Key Record Dates |
Last Update Posted: | September 14, 2012 |
Last Verified: | September 2012 |
Enteral nutrition immunonutrients head and neck cancer |
esophageal cancer chemoradiotherapy H&N or esophageal cancer patients with a chemoradiotherapy treatment. |
Head and Neck Neoplasms Esophageal Neoplasms Malnutrition Neoplasms by Site Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nutrition Disorders |