Clinical Trial: Evaluation of Predictive Risk Factors of Chemotherapy-induced Nausea and Vomiting

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Evaluation of Predictive Risk Factors of Chemotherapy-induced Nausea and Vomiting(CINV)

Brief 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 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 Summary:

  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.

    • 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)


Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the clinical characteristics related to chemotherapy-induced nausea and vomiting in Korean patients [ Time Frame: 2 weeks after chemotherapy ]

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


Original Secondary Outcome: Same as current

Information By: The Catholic University of Korea

Dates:
Date Received: November 12, 2013
Date Started: November 2013
Date Completion: November 2017
Last Updated: March 1, 2016
Last Verified: March 2016