Evaluation of Predictive Risk Factors of Chemotherapy-induced Nausea and Vomiting(CINV)
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the role of some predictive biomarkers for chemotherapy-induced nausea and vomiting
研究概览
简要总结
The most common toxicity of chemotherapy is nausea and vomiting, and appropriate management of these toxicities can help patients improve tolerance for chemotherapy. Anti-emetics including dopamine antagonist, serotonin antagonist, and substance P antagonist administered to patients according to emetogenic risk of chemotherapeutic drugs. However, patients don't always experience same nausea and vomiting for the same drugs. Therefore, it is important to determine the biomarker to predict chemotherapy-induced nausea and vomiting. Some biomarkers studies were done during the chemotherapy. However it is not definite evidence of relations between biomarkers and chemotherapy. We will hope to find any predictive biomarker of CINV.
详细描述
- Primary Objective To evaluate the role of some predictive biomarkers for chemotherapy-induced nausea and vomiting
- Secondary Objective To evaluate the clinical characteristics related to chemotherapy-induced nausea and vomiting in Korean patients
- Study design
Chemotherapy Day Day1 Day3 Day15
Chemotherapy 1st cycle FOLFOX/ FOLFIRI 2nd cycle FOLFOX/ FOLFIRI Blood Sampling 1st sampling (8 a.m.) 2nd sampling (8 a.m.) 3rd sampling (8 a.m.) Evaluation of nausea and vomiting Patient's Diary (Day 1-4) 4. Evaluation of chemotherapy-induced nausea and vomiting
- Patient's Diary consisting of the following three elements:
- NCI-CTCAE (National cancer institute-common toxicity criteria adverse event) version 4.0
- 100mm Visual Analog Scale (VAS)
- Functional living index- emesis
- Patients should write 'Patient's Diary' from chemotherapy day 1 to chemotherapy day 4.
- Evaluation of the serum levels of Biomarkers (substance P et. al.) 1) Blood sampling
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
- •Minimum age of 18 years
- •Histologically proven solid organ cancer
- •Eastern Cooperative Oncology Group Performance status 0-2
- •More than 3 months for life expectancy
- •Patients scheduled to receive the first line, first cycle FOLFOX (5-FU, Oxaliplatin, Leucovorin) or FOLFIRI (5-FU, Irinotecan, Leucovorin) chemotherapy
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
排除标准
- •Patients who have nausea and vomiting caused by other reasons such as CNS metastases or gastrointestinal obstruction
- •Patients who were exposed previously to any chemotherapy except adjuvant FL (5-FU and leucovorin)
- •Patients who take anti-emetic drugs or dopamine antagonist within 72 hours prior to administration of chemotherapy
- •Patients who take other drugs that may affect serum level of biomarkers (ex. steroid, megesterol, hormone replacement therapy, parenteral nutrition)
结局指标
主要结局
To evaluate the role of some predictive biomarkers for chemotherapy-induced nausea and vomiting
时间窗: 2 weeks after chemotherapy
Chemotherapy Day Day1 Day3 Day15 Chemotherapy 1. st cycle FOLFOX/ FOLFIRI 2. nd cycle FOLFOX/ FOLFIRI Blood Sampling 1st sampling (8 a.m.) 2nd sampling (8 a.m.) 3rd sampling (8 a.m.) Evaluation of nausea and vomiting Patient's Diary (Day 1-4)
次要结局
- To evaluate the clinical characteristics related to chemotherapy-induced nausea and vomiting in Korean patients(2 weeks after chemotherapy)
研究者
Byoungyong Shim
Associate professor
The Catholic University of Korea