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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01423799
First received: August 24, 2011
Last updated: November 11, 2015
Last verified: November 2015

August 24, 2011
November 11, 2015
July 2012
October 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01423799 on ClinicalTrials.gov Archive Site
QOL assessed by the EORTC QLQ-OG 25 [ Time Frame: QOL will me measured 30 days post-surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Gastrointestinal Cancer
  • Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides
    Nutritional intervention with immuno-nutrients
  • Dietary Supplement: Isocaloric control
    Isocaloric and isonitrogenous control without immuno nutrients
  • Experimental: Nutritional product
    Nutritional intervention containing immuno-nutrients
    Intervention: Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides
  • Active Comparator: Control Group
    Isocaloric and isonitrogenous control without immuno nutrients.
    Intervention: Dietary Supplement: Isocaloric control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
October 2015
October 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01423799
09.54.CLI
No
Not Provided
Not Provided
Nestlé
Nestlé
Not Provided
Principal Investigator: Christophe Mariette, MD University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France
Nestlé
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP