Management of Nausea and Vomiting Chemotherapy-induced in Normandy

Cancer Clinical Trial

— NAVI  

Official title:

Management of Nausea and Vomiting Chemotherapy-induced in Normandy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440465
• Other study ID #: NAVI
• Status: Completed
• Phase: N/A
• First received: September 15, 2011
• Last updated: February 7, 2013
• Start date: July 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Nausea
• Vomiting

Locations

Country	Name	City	State
France	Centre de la Baie	Avranches
France	Centre hospitalier	Bayeux
France	Centre François Baclesse	Caen
France	Centre Maurice Tubiana	Caen
France	Centre hospitalier public du cotentin	Cherbourg-Octeville
France	Centre Jacques Monod	Flers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute nausea and vomiting	acute nausea and vomiting and / or delayed measured by the tool of anti emetic MAT MASCC.	2 years	No