A phase II trial evaluating the effect of olanzapine 5mg for breakthrough nausea and vomiting in patients receiving carboplatin based chemotherapy

Not Applicable

• Conditions: Malignant tumor (lung cancer, gynecological cancer, etc)

• Registration Number: JPRN-UMIN000031823
• Lead Sponsor: Aichi Cancer Center Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-21
• Study Completion: 2019-03-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patients who has history of hypersensitivity or allergy for study drugs or similar compounds. (2) Patients who do not have enough whole body state to the antineoplastic agents treatment (3) Patient undergoing diabetes treatment (4) Patients with symptomatic brain metastasis (5) Patients who has a convulsive disorders that need anticonvulsants therapy. (6) Patients with symptomatic ascites that need therapeutic drainage. (7) Pregnant, breastfeeding or expecting woman, or patients without intention to contraception (8) Patients enforced radiotherapy on the period between 6 days before and 6 days after of the date of first therapy. (9) Patients who are using prophylactic antiemetic therapy drugs other than NK1 receptor antagonist, 5HT3 antagonist or dexamethasone. (10) Patients who take a medicine regularly antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents. (11) Judged by the investigator to be inappropriate for this study (12) Patients who has nausea at the start of chemotherapy (13) Patients who started opioids within 1 week of chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response (no emesis, no rescue medication) rate during 72 hours after administration of olanzapine.

Secondary Outcome Measures

Name	Time	Method
The change of difference and percentage for nausea intensity (scale, 0-10) at 30, 60, 120 min and 24 hour after administration of olanzapine, and the degree of nausea relief (scale, 1-5) at 24 hour. Adverse event.