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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Byoungyong Shim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01993381
First received: November 12, 2013
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition
Chemotherapy-induced Nausea and Vomiting
Moderate Emetogenic Chemotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Predictive Risk Factors of Chemotherapy-induced Nausea and Vomiting(CINV)

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • To evaluate the role of some predictive biomarkers for chemotherapy-induced nausea and vomiting [ Time Frame: 2 weeks after chemotherapy ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • To evaluate the clinical characteristics related to chemotherapy-induced nausea and vomiting in Korean patients [ Time Frame: 2 weeks after chemotherapy ] [ Designated as safety issue: No ]

    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.
      • Evaluate about clinical history of patients


Biospecimen Retention:   Samples Without DNA

blood sampling


Estimated Enrollment: 200
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
chemotherapy induced nausea and vimiting, FOLFOX, FOLFIRI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993381

Locations
Korea, Republic of
St. Vincent's Hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 442-723
Contact: Byoungyong Shim, Ph.D., M.D    82-31-249-8457      
Principal Investigator: Byoungyong Shim, M.D., Ph.D         
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Byoungyong Shim, M.D., Ph.D. Department of medical oncology, The Catholic University of Korea
  More Information

No publications provided

Responsible Party: Byoungyong Shim, Associate professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01993381     History of Changes
Other Study ID Numbers: CINV_CUKorea
Study First Received: November 12, 2013
Last Updated: November 20, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
chemotherapy-induced nausea and vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014