Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment

Phase 3

Completed

• Conditions: Gastrointestinal Cancer
• Interventions: Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides; Dietary Supplement: Isocaloric control

• Registration Number: NCT01423799
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Study Start: 2012-07
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-11
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional product	Nutritional supplements containing arginine, n-3 and nucleotides	Nutritional intervention containing immuno-nutrients
Control Group	Isocaloric control	Isocaloric and isonitrogenous control without immuno nutrients.

Primary Outcome Measures

Name	Time	Method
Quality of Life (QOL), measured with the EORTC QLQ-C30	QOL will me measured 30 days post-surgery

Secondary Outcome Measures

Name	Time	Method
QOL assessed by the EORTC QLQ-OG 25	QOL will me measured 30 days post-surgery

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire de Lille; 🇫🇷 Lille, France