The objective of this study is to investigate the efficacy of olanzapine as compared to neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
62
8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy
20 mg IV on day 1 pre-chemotherapy
150 mg IV on day 1 pre-chemotherapy
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)
Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.
Time frame: 120 hours post initiating chemotherapy during cycle 1
Rate of Complete Response in the Acute Time Period (0 - 24 Hours Post-chemotherapy)
Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.
Time frame: 24 hours post initiating chemotherapy during cycle 1
Rate of Complete Response in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)
Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.
Time frame: 24-120 hours post initiating chemotherapy during cycle 1
Rate of no Nausea in the Acute Time Period (0 - 24 Hours Post-chemotherapy)
Patients will record daily levels of nausea after chemotherapy using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).
Time frame: 24 hours post initiating chemotherapy during cycle 1
Rate of no Nausea in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)
Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).
Time frame: 120 hours post initiating chemotherapy during cycle 1
Rate of no Nausea in the Overall Time Period (0 - 120 Hours Post-chemotherapy)
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5 mg by mouth on days 1-4 of chemotherapy (taken at night)
5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).
Time frame: 120 hours post initiating chemotherapy during cycle 1
Mean Somnolence Score
Patients will record daily levels of undesired sedation using a Likert scale ranging from 0 to 10 (0 indicating no undesired sedation; 10 indicating maximum level of undesired sedation).
Time frame: assessed daily, and reported at day 6 post final study treatment
Mean Increased-appetite Score
Patients will record daily levels of undesired increase in appetite using a Likert scale ranging from 0 to 10 (0 indicating no undesired increase in appetite; 10 indicating maximum level of undesired increase in appetite).
Time frame: assessed daily, and reported at day 6 post final study treatment