INEC Study: Immuno-modulating Enteral Nutrition in Cancer (NCT00333099) | Clinical Trial Compass
CompletedPhase 4
INEC Study: Immuno-modulating Enteral Nutrition in Cancer
France250 participantsStarted 2006-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.