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

Chemotherapy-induced Nausea and Vomiting research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chemotherapy-induced Nausea and Vomiting

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

CINV of FOLFOX, FOLFIRImoderate emetogenic chemotherapy

Study Status

Recruiting

Start Date: November 2013

Completed Date: November 2017

Phase: N/A

Type: Observational

Design:

Primary Outcome: To evaluate the role of some predictive biomarkers for chemotherapy-induced nausea and vomiting

Secondary Outcome: To evaluate the clinical characteristics related to chemotherapy-induced nausea and vomiting in Korean patients

Study sponsors, principal investigator, and references

Principal Investigator: Byoungyong Shim, M.D., Ph.D.

Lead Sponsor: The Catholic University of Korea

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01993381

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