Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment (Neoimmune)
Primary Purpose
Gastrointestinal Cancer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Nutritional supplements containing arginine, n-3 and nucleotides
Isocaloric control
Sponsored by
About this trial
This is an interventional supportive care trial for Gastrointestinal Cancer focused on measuring Quality of life, Cancer, Immunonutrition
Eligibility Criteria
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.
Sites / Locations
- Centre Hospitalier Régional Universitaire de Lille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nutritional product
Control Group
Arm Description
Nutritional intervention containing immuno-nutrients
Isocaloric and isonitrogenous control without immuno nutrients.
Outcomes
Primary Outcome Measures
Quality of Life (QOL), measured with the EORTC QLQ-C30
Secondary Outcome Measures
QOL assessed by the EORTC QLQ-OG 25
Full Information
NCT ID
NCT01423799
First Posted
August 24, 2011
Last Updated
November 11, 2015
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT01423799
Brief Title
Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment
Acronym
Neoimmune
Official Title
Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
Quality of life, Cancer, Immunonutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional product
Arm Type
Experimental
Arm Description
Nutritional intervention containing immuno-nutrients
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Isocaloric and isonitrogenous control without immuno nutrients.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional supplements containing arginine, n-3 and nucleotides
Intervention Description
Nutritional intervention with immuno-nutrients
Intervention Type
Dietary Supplement
Intervention Name(s)
Isocaloric control
Intervention Description
Isocaloric and isonitrogenous control without immuno nutrients
Primary Outcome Measure Information:
Title
Quality of Life (QOL), measured with the EORTC QLQ-C30
Time Frame
QOL will me measured 30 days post-surgery
Secondary Outcome Measure Information:
Title
QOL assessed by the EORTC QLQ-OG 25
Time Frame
QOL will me measured 30 days post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Mariette, MD
Organizational Affiliation
University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Learn more about this trial
Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment
We'll reach out to this number within 24 hrs