A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy
A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
140
olanzapine 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
placebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, Thailand
RECRUITINGtotal protection rate of nausea and vomiting
Proportion of patients without vomiting or requiring rescue therapy and VAS nausea score of less than 25 mm
Time frame: 5 days
no nausea rate
Time frame: 5 days
severity of nausea and vomiting
Number of patients with grade of nausea or vomiting according to CT-CAE
Time frame: 5 days
adverse events
Number of patients with other adverse event(s)
Time frame: 5 days
rescue therapy
Number of patients requiring additional therapy
Time frame: 5 days
quality of life score
EQ-5D-5L score
Time frame: 5 days
Cost
medical cost excluding chemotherapy and prophylactic measures
Time frame: 5 days
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