Gastrointestinal Cancer
Conditions
Keywords
Quality of life, Cancer, Immunonutrition
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNutritional supplements containing arginine, n-3 and nucleotides
Nutritional intervention with immuno-nutrients
DIETARY_SUPPLEMENTIsocaloric control
Isocaloric and isonitrogenous control without immuno nutrients
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life (QOL), measured with the EORTC QLQ-C30 | QOL will me measured 30 days post-surgery |
Secondary
| Measure | Time frame |
|---|---|
| QOL assessed by the EORTC QLQ-OG 25 | QOL will me measured 30 days post-surgery |
Countries
France
Outcome results
None listed