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

This study is currently recruiting participants.
Verified by Nestle Clinical Nutrition, April 2008

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

MedlinePlus related topics:   Cancer   

Drug Information available for:   Glutamine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment
  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     Recruiting
      Lyon, France, 69008
CHU Charles Nicolle     Not yet recruiting
      Rouen, France, 76000

Sponsors and Collaborators
Nestle Clinical Nutrition

Investigators
Principal Investigator:     Pierre SENESSE, MD     CRLC Val d'Aurelle    
  More Information


Study ID Numbers:   06.23.CLI
First Received:   March 1, 2007
Last Updated:   April 28, 2008
ClinicalTrials.gov Identifier:   NCT00455247
Health Authority:   France: Ministry of Health

ClinicalTrials.gov processed this record on October 22, 2008




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