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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01423799
Other study ID # 09.54.CLI
Secondary ID
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


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
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