This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Nestlé Identifier:
First received: August 24, 2011
Last updated: November 11, 2015
Last verified: November 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment

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 ]

Secondary Outcome Measures:
  • QOL assessed by the EORTC QLQ-OG 25 [ Time Frame: QOL will me measured 30 days post-surgery ]

Enrollment: 300
Study Start Date: July 2012
Study Completion Date: October 2015
Primary Completion Date: October 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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01423799

Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59037
Sponsors and Collaborators
Principal Investigator: Christophe Mariette, MD University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France
  More Information

Responsible Party: Nestlé Identifier: NCT01423799     History of Changes
Other Study ID Numbers: 09.54.CLI
Study First Received: August 24, 2011
Last Updated: November 11, 2015

Keywords provided by Nestlé:
Quality of life

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases processed this record on August 16, 2017