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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01423799
First received: August 24, 2011
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Cancer
Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides
Dietary Supplement: Isocaloric control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Quality of Life (QOL), measured with the EORTC QLQ-C30 [ Time Frame: QOL will me measured 30 days post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QOL assessed by the EORTC QLQ-OG 25 [ Time Frame: QOL will me measured 30 days post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 358
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423799

Contacts
Contact: Anurag Singh +41 21 785-9398 anurag.singh@rdls.nestle.com

Locations
France
Centre Hospitalier Régional Universitaire de Lille Recruiting
Lille, France, 59037
Contact: Christophe Mariette, Professor       christophe.mariette@chru-lille.fr   
Principal Investigator: Christophe Mariette, Professor         
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Christophe Mariette, MD University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01423799     History of Changes
Other Study ID Numbers: 09.54.CLI
Study First Received: August 24, 2011
Last Updated: May 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nestlé:
Quality of life
Cancer
Immunonutrition

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014