NCT00455247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2007

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

4.3 years

First QC Date

March 1, 2007

Last Update Submit

June 4, 2013

Conditions

Digestive Cancers

Interventions

GlutamineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy
  • Sepsis
  • Concomitant radiotherapy, except analgesic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Institut Sainte-Catherine

Avignon, France

Location

CH Béziers

Béziers, France

Location

CRLCC Léon Bérard

Lyon, 69008, France

Location

CRLC Val d'Aurelle

Montpellier, 34090, France

Location

CHU Montpellier

Montpellier, France

Location

CH Perpignan

Perpignan, France

Location

CHU Charles Nicolle

Rouen, 76000, France

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Pierre SENESSE, MD

    CRLC Val d'Aurelle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 1, 2007

First Posted

April 3, 2007

Study Start

October 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

FR(7)