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

This study has been completed.
Sponsor:
Information provided by:
Nestlé
ClinicalTrials.gov Identifier:
NCT00455247
First received: March 1, 2007
Last updated: June 4, 2013
Last verified: June 2013
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Glutamine
U.S. FDA Resources

Further study details as provided by Nestlé:

Study Start Date: October 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with GI neoplasm
  • Patient that must start a (new) line of chemotherapy with at least 2 cycles
  • Age > 18 ans
  • Exclusively orally fed
  • Life expectancy more than 3 months
  • Intravenous 5FU-based chemotherapy with 2 or 3-week cycles
  • Hematological toxicities from previous chemotherapies terminated or <= 2

Exclusion Criteria:

  • Positive HIV status
  • Pregnant or lactating woman
  • Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
  • Patient having diarrhoea of grade > 1 for more than 2 weeks before the inclusion
  • State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy
  • Sepsis
  • Concomitant radiotherapy, except analgesic radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455247

Locations
France
Institut Sainte-Catherine
Avignon, France
CH Béziers
Béziers, France
CRLCC Léon Bérard
Lyon, France, 69008
CRLC Val d'Aurelle
Montpellier, France, 34090
CHU Montpellier
Montpellier, France
CH Perpignan
Perpignan, France
CHU Charles Nicolle
Rouen, France, 76000
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Pierre SENESSE, MD CRLC Val d'Aurelle
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00455247     History of Changes
Other Study ID Numbers: 06.23.CLI
Study First Received: March 1, 2007
Last Updated: June 4, 2013
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on June 18, 2013