Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.
Olanzapine-containing regimens for CINV provide high complete response (CR) rate in patients receiving high emetogenic chemotherapy. Olanzapine may be more effective than aprepitant in this setting but cheaper. However, there is no strong evidence supporting the advantages of olanzapine over aprepitant - and this is the reason why aprepitant is still the standard of care. Due to high cost aprepitant can be not affordable in low- and middle income countries; this compromises quality of life of cancer patients. On the other hand, recommended olanzapine-based regimen includes palonosetron, whose price is quite high as well and undesired sedation is a common side effect for olanzapine doses that currently recommended, these adverse events precludes wide use of olanzapine in oncology. Development of effective, tolerable and affordable regimen for CINV prophylaxis based on low-dose olanzapine and short-acting 5-HT3 inhibitors can improve quality of care for many cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Olanzapine 5 mg/day will be administered orally on days 0-4 of chemotherapy cycle (before bedtime)
Aprepitant 125 mg orally will be administered on day 1 of chemotherapy cycle; 80 mg - on days 2 and 3.
Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy)
N.N. Blokhin Cancer Research Center
Moscow, Russia
RECRUITINGNausea control
Complete control of nausea (ie, no nausea) in overall treatment period (0-120 hours after chemotherapy).
Time frame: 0-120 hours after chemotherapy
Complete Response Rate in Overall Treatment Period
Complete response rate (ie, no vomiting, no use of rescue medication) in 0-120 hours after chemotherapy
Time frame: 0-120 hours after chemotherapy
Rate of undesired sedation
Rate of undesired sedation 0-120 hours after chemotherapy
Time frame: 0-120 hours after chemotherapy
Complete Response Rate in Acute Treatment Period
Complete response rate (ie, no vomiting, no use of rescue medication) in 0-24 hours after chemotherapy
Time frame: 0-24 hours after chemotherapy
Complete Response Rate in Delayed Treatment Period
Complete response rate (ie, no vomiting, no use of rescue medication) in 24-120 hours after chemotherapy
Time frame: 24-120 hours after chemotherapy
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Dexamethasone 8 mg IV on day 1 of chemotherapy cycle; 8 mg IV or orally on days 2-3 (as standard component of antiemetic therapy)