Chemotherapy-induced Nausea and VomitingNCT01993381
Evaluation of Predictive Risk Factors of Chemotherapy-induced Nausea and Vomiting
An observational study of Chemotherapy-induced Nausea and Vomiting, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to receive the first line, first cycle FOLFOX (5-FU, Oxaliplatin, Leucovorin) or FOLFIRI (5-FU, Irinotecan, Leucovorin) chemotherapy
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital
Suwon, Gyeonggi-do, 442-723
Byoungyong Shim, Ph.D., M.D, 82-31-249-8457
Byoungyong Shim, M.D., Ph.D
About this study
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.
Read the detailed description
- 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)
- 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
- 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.
- ELISA test for biomarkers (Sample 1,2,3)
- 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
- 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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- chemotherapy-induced nausea and vomiting
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CINV of FOLFOX, FOLFIRI | moderate emetogenic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the role of some predictive biomarkers for chemotherapy-induced nausea and vomiting
Chemotherapy Day Day1 Day3 Day15
Chemotherapy
- st cycle FOLFOX/ FOLFIRI
- 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)
Measured: 2 weeks after chemotherapy
Secondary outcomes (1)
To evaluate the clinical characteristics related to chemotherapy-induced nausea and vomiting in Korean patients
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.
- Evaluate about clinical history of patients
Measured: 2 weeks after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byoungyong Shim, The Catholic University of Korea
- Investigators
- Byoungyong Shim, M.D., Ph.D., Principal investigator, Department of medical oncology, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993381
- Sponsor's protocol ID
- CINV_CUKorea
- Status last verified
- Jun 2017
- First submitted
- 12 Nov 2013
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Risk Factors of Chemotherapy-induced Nausea and Vomiting(CINV)
- ClinicalTrials.gov ID
- NCT01993381
- Acronym / sponsor ID
- CINV_CUKorea
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- chemotherapy-induced nausea and vomiting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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)
- 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
- 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.
- ELISA test for biomarkers (Sample 1,2,3)
- 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CINV of FOLFOX, FOLFIRI | – | –moderate emetogenic chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to receive the first line, first cycle FOLFOX (5-FU, Oxaliplatin, Leucovorin) or FOLFIRI (5-FU, Irinotecan, Leucovorin) chemotherapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the role of some predictive biomarkers for chemotherapy-induced nausea and vomiting
Time frame: 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)
1 secondary outcome
To evaluate the clinical characteristics related to chemotherapy-induced nausea and vomiting in Korean patients
Time frame: 2 weeks after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Chemotherapy-induced Nausea and Vomiting
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byoungyong Shim, M.D., Ph.D. principal investigator
Department of medical oncology, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Nausea and Vomiting, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the role of some predictive biomarkers for chemotherapy-induced nausea and vomiting (time frame: 2 weeks after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.