OLZOINV study

JRCT ID: jRCTs031220008

Registered date:19/04/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Opioid-induced nausea and vomiting
• Date of first enrollment: 03/06/2022
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Olanzapine arm

Outcome(s)

• Primary Outcome: Complete control rate during the 5 days of treatment with initiation of olanzapine.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Satomi Eriko
• Secondary Sponsor: Japanese society of palliative medicine