Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment

Conditions
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Gastrointestinal Cancer

Intervention / Treatment
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* Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides
* Dietary Supplement: Isocaloric control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional product<br>Nutritional intervention containing immuno-nutrients | Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides<br>* Nutritional intervention with immuno-nutrients<br>|
| Active Comparator: Control Group<br>Isocaloric and isonitrogenous control without immuno nutrients. | Dietary Supplement: Isocaloric control<br>* Isocaloric and isonitrogenous control without immuno nutrients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL), measured with the EORTC QLQ-C30 |  | QOL will me measured 30 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL assessed by the EORTC QLQ-OG 25 |  | QOL will me measured 30 days post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Cancer, Immunonutrition