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

November 21, 2025 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 Francois 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

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
Number of Participants With Acute Nausea and Vomiting
Time Frame: 24 hours
acute nausea and vomiting and/or delayed measured by the tool of anti emetic MAT MASCC. Such self-administered questionnaire was found to be sensitive to detect the different dimensions of chemo-induced nausea and vomiting and to perform well against a daily assessment of nausea and vomiting. The MAT questionnaire separately asks for acute (within 24h of initial administration of chemotherapy) and delayed (from 24h to 4 days after chemotherapy) chemo-induced nausea and vomiting by asking the patient to fill out the first page the day after chemotherapy referring to the first 24h following chemotherapy and the second page 4 days after chemotherapy concerning the period from the day after to 4 days after chemotherapy. Clinically significant nausea was defined by reported nausea intensity >=3 on a 0-10 scale, 10 being the highest intensity of nausea. Clinically significant chemo induced nausea/vomiting was defined by greater than or equal to one nausea episode/vomiting, respectively.
24 hours

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 Francois 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 (Estimated)

September 26, 2011

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

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.

Clinical Trials on Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe