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

Sponsor
Nestlé (Industry)
Overall Status
Completed
CT.gov ID
NCT00455247
Collaborator
(none)
7
Locations
51
Duration (Months)

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Sainte-Catherine Avignon France
    2 CH Béziers Béziers France
    3 CRLCC Léon Bérard Lyon France 69008
    4 CRLC Val d'Aurelle Montpellier France 34090
    5 CHU Montpellier Montpellier France
    6 CH Perpignan Perpignan France
    7 CHU Charles Nicolle Rouen France 76000

    Sponsors and Collaborators

    • Nestlé

    Investigators

    • Principal Investigator: Pierre SENESSE, MD, CRLC Val d'Aurelle

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00455247
    Other Study ID Numbers:
    • 06.23.CLI
    First Posted:
    Apr 3, 2007
    Last Update Posted:
    Jun 5, 2013
    Last Verified:
    Jun 1, 2013

    Study Results

    No Results Posted as of Jun 5, 2013