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

This study has been completed.
Information provided by (Responsible Party):
Centre Francois Baclesse Identifier:
First received: September 15, 2011
Last updated: February 7, 2013
Last verified: February 2013
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.

Cancer Nausea Vomiting

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Management of Nausea and Vomiting Chemotherapy-induced in Normandy

Resource links provided by NLM:

Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • acute nausea and vomiting [ Time Frame: 2 years ]
    acute nausea and vomiting and / or delayed measured by the tool of anti emetic MAT MASCC.

Enrollment: 300
Study Start Date: July 2011
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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
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Please refer to this study by its identifier: NCT01440465

Centre de la Baie
Avranches, France, 50307
Centre hospitalier
Bayeux, France, 14400
Centre Maurice Tubiana
Caen, France, 14052
Centre François Baclesse
Caen, France, 14076
Centre hospitalier public du cotentin
Cherbourg-Octeville, France, 50100
Centre Jacques Monod
Flers, France, 61104
Sponsors and Collaborators
Centre Francois Baclesse
Principal Investigator: JOLY Florence, Pr Centre François Baclesse
  More Information

Responsible Party: Centre Francois Baclesse Identifier: NCT01440465     History of Changes
Other Study ID Numbers: NAVI
Study First Received: September 15, 2011
Last Updated: February 7, 2013

Keywords provided by Centre Francois Baclesse:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on September 20, 2017