Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment
| Registry | NCT01423799, acronym Neoimmune |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, supportive care |
| Enrollment | 300 (Actual) |
| Sponsor | Société des Produits Nestlé (SPN) (Industry) |
| Conditions | Gastrointestinal Cancer |
| Interventions | Nutritional supplements containing arginine, n-3 and nucleotides, Isocaloric control (Dietary supplement) |
| Dates | start 2012-07-01, primary completion 2015-10-01, completion 2015-10-01, first posted 2011-08-26, last updated 2015-11-13 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Gastrointestinal Cancer All trials of Nutritional supplements containing arginine, n-3 and nucleotides All trials of Isocaloric control
The purpose of this study is to compare the health-related quality of life following dietary supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet supplement in patients suffering from upper digestive tract neoplasia undergoing oncological treatment.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Nutritional product | Experimental | Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides | Nutritional intervention containing immuno-nutrients |
| Control Group | Active comparator | Dietary Supplement: Isocaloric control | Isocaloric and isonitrogenous control without immuno nutrients. |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: * Histologically proven GI cancer. * Age ≥ 18 years. * Life expectancy more than 3 months. * Female patients of child-bearing potential must be willing to employ effective contraception during the study period. * Female patients of child-bearing potential must have a negative serum Beta Human Chorionic Gonadotrophin (βhCG) test at Visit 0. * The patient is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements. * The patient voluntarily gives written informed consent to participate in the study. Exclusion Criteria: * Severe concomitant clinical conditions other than the previously untreated digestive tract cancer that jeopardise the protocol follow-up. * The patient is pregnant or is a lactating woman. * Currently participating or having participated in another interventional clinical trial related to nutritional support during the 30 days prior to the beginning of the study product intake, except if this other interventional trial is testing new drug or surgical intervention. (Note: participation in a prior or concurrent clinical trial not related to nutritional support does not exclude the patient from participation.) * Other malignancies in the last 5 years (except for successfully treated in situ basocellular skin and in situ cervical uterine tumours). * Patients with more than 20% weight loss over a 6 months period.
| Facility | City | Country | Status |
|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Lille | Lille | France |