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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00455247
First Posted: April 3, 2007
Last Update Posted: June 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nestlé
  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
Primary Purpose: Prevention

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00455247     History of Changes
Other Study ID Numbers: 06.23.CLI
First Submitted: March 1, 2007
First Posted: April 3, 2007
Last Update Posted: June 5, 2013
Last Verified: June 2013