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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01440465
First received: September 15, 2011
Last updated: February 7, 2013
Last verified: February 2013
History of Changes

September 15, 2011
February 7, 2013
July 2011
January 2013   (final data collection date for primary outcome measure)
acute nausea and vomiting [ Time Frame: 2 years ] [ Designated as safety issue: No ]
acute nausea and vomiting and / or delayed measured by the tool of anti emetic MAT MASCC.
Same as current
Complete list of historical versions of study NCT01440465 on ClinicalTrials.gov Archive Site
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Management of Nausea and Vomiting Chemotherapy-induced in Normandy
Management of Nausea and Vomiting Chemotherapy-induced in Normandy

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.
Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients treated with first line chemotherapy with intravenous (IV) to solid tumors or hematologic.
  • Cancer
  • Nausea
  • Vomiting
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
February 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01440465
NAVI
Yes
Centre Francois Baclesse
Centre Francois Baclesse
Not Provided
Principal Investigator: JOLY Florence, Pr Centre François Baclesse
Centre Francois Baclesse
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP