Chemotherapy-induced Nausea and Vomiting Clinical Trial
Official title:
Evaluation of Predictive Risk Factors of Chemotherapy-induced Nausea and Vomiting(CINV)
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.
1. Primary Objective To evaluate the role of some predictive biomarkers for
chemotherapy-induced nausea and vomiting
2. Secondary Objective To evaluate the clinical characteristics related to
chemotherapy-induced nausea and vomiting in Korean patients
3. 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:
1. NCI-CTCAE (National cancer institute-common toxicity criteria adverse event)
version 4.0
2. 100mm Visual Analog Scale (VAS)
3. Functional living index- emesis
- Patients should write 'Patient's Diary' from chemotherapy day 1 to chemotherapy
day 4.
5. Evaluation of the serum levels of Biomarkers (substance P et. al.) 1) Blood sampling
- Sample 1: 1st cycle, chemotherapy starting day 1, fasting 8 a.m.
- Sample 2: 1st cycle, chemotherapy day 3, fasting 8 a.m.
- Sample 3: 2nd cycle, chemotherapy starting day 1 (day 15 after 1st cycle
chemotherapy), fasting 8 a.m.
2) ELISA test for biomarkers (Sample 1,2,3)
5. Visiting Schedule
Screening Chemotherapy Time of Visit D-3 to -1 1st day of 1st cycle (Day 1) 3rd day of 1st
cycle (Day 3) 4th day of 1st cycle (Day4) 1st day of 2nd cycle (Day 15) Inclusion/exclusion
criteria x Informed consent x Distribution of patient's diary x Blood sampling x x x Return
of patient's diary x
6. Statistical methods and data analysis Continuous variables, including serum levels of
biomarkers, are expressed as median, minimum, and maximum values. Comparisons of continuous
variables are made using the Mann-Whitney U test and the Kruskal-Wallis test. The chi-square
test is used for comparisons of categorical variables.
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