Cancer, Nausea, Vomiting
Conditions
Keywords
chemotherapy, cancer, nausea, vomiting
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.
Interventions
None listed
Sponsors
Centre Francois Baclesse
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Nausea and Vomiting | 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. |
Countries
France
Participant flow
Pre-assignment details
Eligible patients were older than 18 years, chemotherapy naive, and with a histologically proven solid malignant tumour requiring chemotherapy whatever the stage of the disease. Patients had to understand the procedures and agree to participate in the study by giving written informed consent.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Arm Chemotherapy-naïve patients are included during the first cycle of treatment to assess frequency and intensity of chemotherapy-induced nausea and vomiting. | 291 |
| Total | 291 |
Baseline characteristics
| Characteristic | Experimental Arm | — |
|---|---|---|
| Age, Continuous | 57 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 248 Participants | — |
| Sex: Female, Male Male | 43 Participants | — |
| Stage of the disease Adjuvant setting | 219 Participants | — |
| Stage of the disease Metastatic setting | 45 Participants | — |
| Stage of the disease Neo-adjuvant setting | 27 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 291 |
| other Total, other adverse events | 260 / 291 |
| serious Total, serious adverse events | 1 / 291 |
Outcome results
Primary
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
Population: Data from MAT to measure chemotherapy-induced nausea and vomiting were available for 248 patients of the 291 included (85.2%).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental arm | Number of Participants With Acute Nausea and Vomiting | 101 Participants |