Opioid-induced nausea and vomiting
Conditions
Interventions
Olanzapine arm
Sponsors
Satomi Eriko
Japanese society of palliative medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or clinically malignant disease -An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3 -Patients with moderate to severe cancer pain needed to treat with opioid analgesics as morphine, oxycodone,hydromorphone, etc -Ability to provide informed written consent -An age of > =18 years -Capable to take medicine orally -A life expectancy of 4 weeks or longer -Able to complete study assessments and complying with the study procedures
Exclusion criteria
Exclusion criteria: -Diabetes mellitus -Had vomiting or nausea (> =CTCAE grade2) -Symptomatic intracranial disease as brain metastasis,nerve dissemination -Had received radiotherapy to the head, abdomen, or pelvis within 6 days before and during the study period -Had received new drugs with emetic or antiemetic action within 48 hours before study initiation -Had received regular strong opioid analgesics within 1 month before study initiation -Had a history of hypersensitivity or any contraindication to olanzapine -Had received new chemotherapeutic agents within 1 week before treatment with the study drug and during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete control rate during the 5 days of treatment with initiation of olanzapine. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Complete Response Rate during the 5 days of treatment with initiation of olanzapine. 2) Total Control Rate during the 5 days of treatment with initiation of olanzapine. 3) Time to the first emetic episode 4) Time to the first rescue antiemetics administration 5) Time to Treatment Failure 6) The proportion of patients who had no emetic episode during the study period 7) The cumulative number of emetic episodes in patients who had at least one emetic episode during the study period 8) The proportions of patients with no nausea, no moderate nausea (CTCAE grade2>) 9) Nausea numerical rating scale 10) The proportion of patients who had no rescue antiemetics during the study period 11) The cumulative number of rescues antiemetics during the study period 12) Opioid daily dose (including rescue opioid) 13) Oral intake 14) FACT-G 15) Pain numerical rating scale 16) ESAS-j 17) Adverse events (CTCAE ver.5) 18) Patient satisfaction 19) Feasibility | — |
Contacts
Public ContactEriko Satomi
National Cancer Center Hospital
Outcome results
None listed