Clinical Research Directory
Browse clinical research sites, groups, and studies.
AKY15-HK-301_NEPA Study
Sponsor: Chinese University of Hong Kong
Summary
Nausea and vomiting (feeling sick to your stomach and throwing up) are two of the most common unpleasant side effects of chemotherapy agents (drugs specifically used to treat cancer) that will be used for cancer treatment. If nausea and vomiting are not controlled, they could lead to dehydration, poor nutrition and a longer time in the hospital. Nausea and vomiting usually occur in response to conditions that affect the gut and the vomiting center, which is an area in the brain. Netupitant and palonosetron are drugs that are thought to block the activation of certain types of chemicals in these areas (brain and gut) and, therefore, to prevent or reduce the severity of nausea and vomiting. Nausea and vomiting caused by chemotherapy is classified into two patterns based on the time of onset or start. Acute nausea and vomiting start within 24 hours of chemotherapy administration. Delayed nausea and vomiting starts approximately 2-5 days after chemotherapy administration. Regardless of when the nausea and vomiting start, these symptoms are usually treated with not just one drug, but a combination of drugs. In this study you will receive the study drug, which is a fixed combination of netupitant and palonosetron. This is an open label single arm study. The main purpose of this study or clinical trial is to learn more about the effect (how well it works) of the fixed combination of netupitant and palonosetron (NEPA) in preventing nausea and vomiting associated with chemotherapy in Hong Kong oncology patients receiving (neo)-adjuvant chemotherapy treatment consists of adriamycin and cyclophosphamide for breast cancer.
Official title: Open Label Single Arm Study for NEPA [Oral Fixed-dose Combination of 300 mg Netupitant and 0.50 mg Palonosetron] in Hong Kong Oncology Patients Receiving (Neo)-Adjuvant Chemotherapy Treatment Consists of Adriamycin and Cyclophosphamide for Breast Cancer
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2018-02-27
Completion Date
2028-12-31
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
NEPA
Day 1 of each chemotherapy cycle: 1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded.
Locations (1)
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong