Prevalence of Anticipatory Nausea and Vomiting in Cancer Patients Exposed to Highly Emetogenic Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Prevalence of anticipatory nausea and vomiting in cancer patients undergoing highly emetogenic chemotherapy regimen
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological confirmation of cancer;
- •Patients who will start chemotherapy with a high-grade emetogenic scheme and who have received adequate antiemetic prophylaxis;
- •No previous cancer treatment for the current diagnosis (excluding surgery);
排除标准
- •Patients who have an inability to answer the questionnaire, due to lack of discernment to answer the questions reliably;
- •Patients who report vomiting during the 24 hours prior to the first cycle of chemotherapy treatment;
- •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);
- •Patients using opioids or illicit drugs;
- •Alcoholism;
结局指标
主要结局
Prevalence of anticipatory nausea and vomiting in cancer patients undergoing highly emetogenic chemotherapy regimen
时间窗: 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.
次要结局
- Quality of life - Functional Living Index-Emesis (FLIE)(Days 1 (before starting chemotherapy) and 6 (after chemotherapy))
- Patient's daily diary(At the end of Cycle 1 up to the day of Cycle 2 (each cycle is 15 to 21 days))
研究者
Rafaela de Brito Alves
Principal Investigator
Instituto Brasileiro de Controle do Cancer