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Clinical Trials/JPRN-jRCTs031220008
JPRN-jRCTs031220008
Recruiting
Phase 2

Exploratory study investigating the efficacy, safety of prophylactic olanzapine for opioid-induced nausea and vomiting in patients with cancer - JORTC-PAL20

Satomi Eriko0 sites35 target enrollmentApril 19, 2022
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ConditionsOpioid-induced nausea and vomiting

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Opioid-induced nausea and vomiting
Sponsor
Satomi Eriko
Enrollment
35
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 19, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Satomi Eriko

Eligibility 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

  • •\-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.

Outcomes

Primary Outcomes

Not specified

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