Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment

Gastrointestinal Cancer Clinical Trial

— Neoimmune  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423799
• Other study ID #: 09.54.CLI
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2011
• Last updated: November 11, 2015
• Start date: July 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 (ßhCG) 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Dietary Supplement:
• Nutritional supplements containing arginine, n-3 and nucleotides
Nutritional intervention with immuno-nutrients
• Isocaloric control
Isocaloric and isonitrogenous control without immuno nutrients

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (QOL), measured with the EORTC QLQ-C30		QOL will me measured 30 days post-surgery	No
Secondary	QOL assessed by the EORTC QLQ-OG 25		QOL will me measured 30 days post-surgery	No