Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment (Neoimmune)

November 11, 2015 updated by: Nestlé

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Centre Hospitalier Régional Universitaire de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Christophe Mariette, MD, University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 24, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 11, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.54.CLI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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