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.

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Key information

Conditions

Cancer Nausea Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de la Baie, Avranches, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Number of Participants With Acute Nausea and Vomiting

Time frame: 24 hours

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.

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: NAVI

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 26, 2011
Registry last updated: Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed