Efficacy of an Oral Formula in Prevention of Anti-Cancer Therapy Side Effects

This study is currently recruiting participants.

Verified by Nestle Clinical Nutrition, June 2009

First Received: March 1, 2007 Last Updated: June 8, 2009 History of Changes

Sponsored by:	Nestle Clinical Nutrition
Information provided by:	Nestle Clinical Nutrition
ClinicalTrials.gov Identifier:	NCT00455247

Purpose

Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner.

Condition	Intervention	Phase
Digestive Cancers	Drug: Glutamine	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Glutamine

U.S. FDA Resources

Further study details as provided by Nestle Clinical Nutrition:

Study Start Date:

October 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patient with GI neoplasm
Newly diagnosed cancer patient that should undergo anti-cancer treatment or patient that should undergo a new anti-cancer treatment
Age > 18 ans
Orally fed
Having obtained his/her informed consent
Life expectancy more than 3 months

Exclusion Criteria:

Positive HIV status
Pregnant or lactating woman
Currently participating or having participated in another clinical trial during the last prior 1 month to the beginning of this study
Patient regularly having diarrhoea before inclusion
State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy
Sepsis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455247

Contacts

Contact: Pierre SENESSE, MD

+33 4 67 61 85 54

psenesse@valdorel.fnclcc.fr

Locations

France
CRLC Val d'Aurelle	Recruiting
Montpellier, France, 34090
CRLCC Léon Bérard	Terminated
Lyon, France, 69008
CHU Charles Nicolle	Recruiting
Rouen, France, 76000
CHU Montpellier	Recruiting
Montpellier, France

Sponsors and Collaborators

Nestle Clinical Nutrition

Investigators

Principal Investigator:

Pierre SENESSE, MD

CRLC Val d'Aurelle

More Information

No publications provided

Study ID Numbers:	06.23.CLI
Study First Received:	March 1, 2007
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00455247 History of Changes
Health Authority:	France: Ministry of Health

Study placed in the following topic categories:

Glutamine

ClinicalTrials.gov processed this record on September 10, 2009