Management of Nausea and Vomiting Chemotherapy-induced in Normandy

NCT01440465 | Completed Results DMC

• 1 other identifier: NAVI
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 6

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.

Conditions

Cancer; Nausea; Vomiting

Keywords

chemotherapy; cancer; nausea; vomiting

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute Nausea and Vomiting

  acute nausea and vomiting and/or delayed measured by the tool of anti emetic MAT MASCC. Such self-administered questionnaire was found to be sensitive to detect the different dimensions of chemo-induced nausea and vomiting and to perform well against a daily assessment of nausea and vomiting. The MAT questionnaire separately asks for acute (within 24h of initial administration of chemotherapy) and delayed (from 24h to 4 days after chemotherapy) chemo-induced nausea and vomiting by asking the patient to fill out the first page the day after chemotherapy referring to the first 24h following chemotherapy and the second page 4 days after chemotherapy concerning the period from the day after to 4 days after chemotherapy. Clinically significant nausea was defined by reported nausea intensity \>=3 on a 0-10 scale, 10 being the highest intensity of nausea. Clinically significant chemo induced nausea/vomiting was defined by greater than or equal to one nausea episode/vomiting, respectively.

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with first line chemotherapy with intravenous (IV) to solid tumors or hematologic.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (6)

Centre de la Baie

Avranches, 50307, France

Location

Centre hospitalier

Bayeux, 14400, France

Location

Centre Maurice Tubiana

Caen, 14052, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre hospitalier public du cotentin

Cherbourg-Octeville, 50100, France

Location

Centre Jacques Monod

Flers, 61104, France

Location

MeSH Terms

Conditions

Neoplasms; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alexandra LECONTE
• Organization: Centre François Baclesse

a.leconte@baclesse.unicancer.fr

0231455002

Study Officials

• JOLY Florence, Pr

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 26, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-11

Locations

FR (6)