Management of Nausea and Vomiting Chemotherapy-induced in Normandy (NAVI)

February 7, 2013 updated by: Centre Francois Baclesse
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avranches, France, 50307
        • Centre de la Baie
      • Bayeux, France, 14400
        • Centre hospitalier
      • Caen, France, 14076
        • Centre François Baclesse
      • Caen, France, 14052
        • Centre Maurice Tubiana
      • Cherbourg-Octeville, France, 50100
        • Centre Hospitalier Public du Cotentin
      • Flers, France, 61104
        • Centre Jacques Monod

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with first line chemotherapy with intravenous (IV) to solid tumors or hematologic.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute nausea and vomiting
Time Frame: 2 years
acute nausea and vomiting and / or delayed measured by the tool of anti emetic MAT MASCC.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

September 15, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (Estimate)

September 26, 2011

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAVI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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