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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01440465
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : February 8, 2013
Information provided by (Responsible Party):
Centre Francois Baclesse

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
Cancer Nausea Vomiting

Study Type : Observational
Actual Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Management of Nausea and Vomiting Chemotherapy-induced in Normandy
Study Start Date : July 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Centre Francois Baclesse Identifier: NCT01440465     History of Changes
Other Study ID Numbers: NAVI
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013

Keywords provided by Centre Francois Baclesse:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms