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
  Purpose

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
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 ] [ Designated as safety issue: No ]
    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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440465

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

No publications provided

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01440465     History of Changes
Other Study ID Numbers: NAVI
Study First Received: September 15, 2011
Last Updated: February 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Francois Baclesse:
chemotherapy
cancer
nausea
vomiting

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

ClinicalTrials.gov processed this record on September 11, 2014