Management of Nausea and Vomiting Chemotherapy-induced in Normandy

Centre Francois Baclesse300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Cancer Nausea Vomiting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Centre de la Baie

Avranches, France

Centre hospitalier

Bayeux, France

Centre Maurice Tubiana

Caen, France

Centre François Baclesse

Caen, France

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Data from ClinicalTrials.gov

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