Evaluation of Predictive Risk Factors of Chemotherapy-induced Nausea and Vomiting

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.

Study Overview

• Status: Unknown
• Conditions: Chemotherapy-induced Nausea and Vomiting

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 442-723
      • Recruiting
      • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to receive the first line, first cycle FOLFOX (5-FU, Oxaliplatin, Leucovorin) or FOLFIRI (5-FU, Irinotecan, Leucovorin) chemotherapy

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CINV of FOLFOX, FOLFIRI; moderate emetogenic chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 weeks after chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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- emesisPatients should write 'Patient's Diary' from chemotherapy day 1 to chemotherapy day 4.Evaluate about clinical history of patients	2 weeks after chemotherapy

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: Byoungyong Shim, M.D., Ph.D., Department of medical oncology, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 12, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: chemotherapy-induced nausea and vomiting
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: CINV_CUKorea

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED