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NAVI: Management of Nausea and Vomiting Chemotherapy-induced in Normandy

Sponsor
Centre Francois Baclesse (Other)
Overall Status
Completed
CT.gov ID
NCT01440465
Collaborator
(none)
300
Enrollment
6
Locations
19.1
Duration (Months)
50
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study was to evaluate the various parameters involved in the occurrence of nausea / vomiting during the first cycle of chemotherapy for solid tumors or hematologic among a group of chemotherapy-naive patients, despite anti standardized-emetics protocols.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Time Perspective:
    Prospective
    Official Title:
    Management of Nausea and Vomiting Chemotherapy-induced in Normandy
    Study Start Date :
    Jul 1, 2011
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    Feb 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. acute nausea and vomiting [2 years]

      acute nausea and vomiting and / or delayed measured by the tool of anti emetic MAT MASCC.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Aged over 18 years

    • With solid tumors or hematologic in first line chemotherapy, administered intravenously,

    • Able to understand the meaning of the questions

    • Having given their written consent to participate in the survey.

    Exclusion Criteria:
    This does not concern patients who:

    • Do not give their consent for participation

    • Do not speak French

    • Suffer from cognitive deficits

    • Are under therapy

    • Must receive a combination of radio-chemotherapy

    • Present an occlusive syndrome

    • Metastases (s) brain (s) clinically symptomatic (s) or radiologically proven (s) or a (of) tumor (s) brain (s)

    • Have been previously treated with chemotherapy

    • Present a cons-indication to corticosteroids, with anti-serotonin or NK1 receptor inhibitors

    • Pregnant or breastfeeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre de la Baie Avranches France 50307
    2 Centre hospitalier Bayeux France 14400
    3 Centre Maurice Tubiana Caen France 14052
    4 Centre François Baclesse Caen France 14076
    5 Centre hospitalier public du cotentin Cherbourg-Octeville France 50100
    6 Centre Jacques Monod Flers France 61104

    Sponsors and Collaborators

    • Centre Francois Baclesse

    Investigators

    • Principal Investigator: JOLY Florence, Pr, Centre François Baclesse

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Francois Baclesse
    ClinicalTrials.gov Identifier:
    NCT01440465
    Other Study ID Numbers:
    • NAVI
    First Posted:
    Sep 26, 2011
    Last Update Posted:
    Feb 8, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Centre Francois Baclesse
    chemotherapy
    cancer
    nausea
    vomiting
    Additional relevant MeSH terms:
    Nausea
    Vomiting

    Study Results

    No Results Posted as of Feb 8, 2013