Prevalence of Anticipatory Nausea and Vomiting in Cancer Patients Exposed to Highly Emetogenic Chemotherapy
2021年3月4日 更新者：Rafaela de Brito Alves、Instituto Brasileiro de Controle do Cancer
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
50
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
SP
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São Paulo、SP、巴西、03102-002
- 招聘中
- Rafaela de Brito Alves
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接触：
- Felipe José Silva Melo Cruz, PhD
- 邮箱：felipemcruz@yahoo.com.br
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首席研究员：
- Rafaela de Brito Alves, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
It is estimated to recruit a sample of 50 cancer patients, undergoing chemotherapy with high emetogenic grade regimens, at the reference hospital in São Paulo, Brazil.
描述
Inclusion Criteria:
- 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);
Exclusion Criteria:
- 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;
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
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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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prevalence of anticipatory nausea and vomiting in cancer patients undergoing highly emetogenic chemotherapy regimen
大体时间：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.
|
Baseline to 6 days after chemotherapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient's daily diary
大体时间：At the end of Cycle 1 up to the day of Cycle 2 (each cycle is 15 to 21 days)
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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.
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At the end of Cycle 1 up to the day of Cycle 2 (each cycle is 15 to 21 days)
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Quality of life - Functional Living Index-Emesis (FLIE)
大体时间：Days 1 (before starting chemotherapy) and 6 (after chemotherapy)
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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).
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Days 1 (before starting chemotherapy) and 6 (after chemotherapy)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Camilla Vieira de Rebouças, MD、Instituto Brasileiro de Controle do Cancer
- 学习椅：Louize Caroline Marques Oliveira, MD、Instituto Brasileiro de Controle do Cancer
- 首席研究员：Rafaela de Brito Alves, MD、Instituto Brasileiro de Controle do Cancer
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年8月12日
初级完成 (预期的)
2021年8月1日
研究完成 (预期的)
2021年11月1日
研究注册日期
首次提交
2021年3月1日
首先提交符合 QC 标准的
2021年3月4日
首次发布 (实际的)
2021年3月8日
研究记录更新
最后更新发布 (实际的)
2021年3月8日
上次提交的符合 QC 标准的更新
2021年3月4日
最后验证
2020年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.