Status:
COMPLETED
Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Gastrointestinal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01423799
Start Date
July 1 2012
End Date
October 1 2015
Last Update
November 13 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59037