Olanzapine for Nausea/Vomiting Prophylaxis in Recipients of Hematopoietic Stem Cell Transplants
Status:
Recruiting
Trial end date:
2022-08-30
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to see if olanzapine helps to prevent nausea and/or
vomiting (throwing up) when it is added to other medicines in subjects having stem cell
transplants. Subjects will either be given olanzapine or an inactive pill (called a placebo)
before getting any chemotherapy that is known to cause nausea and vomiting. During the study,
the study coordinators will ask the subjects to complete surveys to understand if the patient
is having nausea and vomiting, and if so, how bad it is making the patient feel.
This trial will split subjects into two groups: one group will be given an inactive pill
(placebo), and the other group will be given the active pill (olanzapine). Study coordinators
will collect surveys every morning before chemotherapy and 5 days after the last dose of
chemotherapy. These surveys may be given by members of the study team or possibly on a mobile
device.
Subjects may benefit from being in this research study because olanzapine may reduce the
frequency or severity of chemotherapy-induced nausea and vomiting (CINV). The most common
risks of using olanzapine include possibly becoming more tired, mild dizziness, mild low
blood pressure, and mild muscle "quivering." Other possible adverse effects include low blood
pressure, muscle weakness, increased appetite, weight gain, constipation, and liver function
test changes however these risks are less common in subjects with cancer. In addition, there
may be a change detected in heart rhythm however subjects will be screened for this ahead of
time.