Prevalence of Anticipatory Nausea and Vomiting in Cancer Patients Exposed to Highly Emetogenic Chemotherapy
Study Details
Study Description
Brief Summary
Chemotherapy induced nausea and vomiting are common adverse events related to oncologic treatments. It can have deleterious effect on patients' quality of life and could lead to dose reductions and/or discontinuation of treatment. This study aims to quantify the prevalence of nausea and vomiting induced by highly emetogenic chemotherapy in patients who had adequate antiemetic prophylaxis, also to describe the epidemiologic profile and identify predisposing factors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The investigators will track patients in the first and second cycles of chemotherapy. Information regarding comorbidities, medical history and sociodemographic characteristics will be collected. The impact of nausea and vomiting induced by the treatment on patient's quality of life will be evaluated using the questionnaire Functional Living Index-Emesis - FLIE.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cancer Patients Exposed to Highly Emetogenic Chemotherapy Patients who will start chemotherapy with a high-grade emetogenic scheme and who have received adequate antiemetic prophylaxis. |
Other: Quality-of-life assessment
Patients will be provided the Functional Living Index - Emesis (FLIE) quality of life survey to be completed at time zero (before the application of chemotherapy) and then after 6 day, after application of chemotherapy.
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Outcome Measures
Primary Outcome Measures
- Prevalence of anticipatory nausea and vomiting in cancer patients undergoing highly emetogenic chemotherapy regimen [Baseline to 6 days after chemotherapy]
The prevalence of nausea and vomiting will be determined by the percentage of patients reporting the presence of a symptom at the assessment time point. Participants are asked to report any episodes of nausea and vomiting before (baseline) and up to 6 days after receiving chemotherapy. This result is measured during the first and second cycles of chemotherapy for each patient.
Secondary Outcome Measures
- Patient's daily diary [At the end of Cycle 1 up to the day of Cycle 2 (each cycle is 15 to 21 days)]
Participants must record any episodes of nausea and vomiting in the diary. In addition, the patient must present a score for his symptom, from zero to ten (0 = no symptom / 10 = strong symptom) using the Visual Numerical Analog Scale.
- Quality of life - Functional Living Index-Emesis (FLIE) [Days 1 (before starting chemotherapy) and 6 (after chemotherapy)]
The FLIE questionnaire will be completed on days 1 (before starting chemotherapy) and 6 (after chemotherapy). The FLIE questionnaire consists of a nausea domain and a vomiting domain of nine items each where the patient should rate how much nausea and vomiting have affected the quality of life. For each question the patient will rate how much nausea (or vomiting) has affected an aspect of his quality of life during the past five days. Each question uses a visual analogue scale (where 1= no emesis-7=a great deal).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with histological confirmation of cancer;
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Patients who will start chemotherapy with a high-grade emetogenic scheme and who have received adequate antiemetic prophylaxis;
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No previous cancer treatment for the current diagnosis (excluding surgery);
Exclusion Criteria:
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Patients who have an inability to answer the questionnaire, due to lack of discernment to answer the questions reliably;
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Patients who report vomiting during the 24 hours prior to the first cycle of chemotherapy treatment;
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Patients who have a disease or condition that could cause emesis (ie, metastasis in the central nervous system, gastrointestinal obstruction or metabolic and electrolyte imbalances);
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Patients using opioids or illicit drugs;
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Alcoholism;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rafaela de Brito Alves | São Paulo | SP | Brazil | 03102-002 |
Sponsors and Collaborators
- Instituto Brasileiro de Controle do Cancer
Investigators
- Study Chair: Camilla Vieira de Rebouças, MD, Instituto Brasileiro de Controle do Cancer
- Study Chair: Louize Caroline Marques Oliveira, MD, Instituto Brasileiro de Controle do Cancer
- Principal Investigator: Rafaela de Brito Alves, MD, Instituto Brasileiro de Controle do Cancer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 32148820000000072