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

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. Identifier: NCT00455247
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : June 5, 2013
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Brief Summary:
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 or disease Intervention/treatment Phase
Digestive Cancers Drug: Glutamine Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : October 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00455247

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
Principal Investigator: Pierre SENESSE, MD CRLC Val d'Aurelle Identifier: NCT00455247     History of Changes
Other Study ID Numbers: 06.23.CLI
First Posted: April 3, 2007    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013