A placebo-controlled, double-blind, randomized phase III study to validate the efficacy of standard antiemetic therapy plus olanzapine for the prevention of chemotherapy-induced nausea and vomiting associated with chemotherapy including carboplatin

A placebo-controlled, double-blind, randomized phase III study to validate the efficacy of standard antiemetic therapy plus olanzapine for the prevention of chemotherapy-induced nausea and vomiting associated with chemotherapy including carboplatin - A phase III study to verify the usefulness of standard antiemetic therapy plus olanzapine for chemotherapy including carboplatin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037749

Enrollment

380

Registered

2019-09-01

Start date

2019-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced lung cancer

Interventions

For 4 days Olanzapine 5mg or placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Advanced lung cancer patients who receive carboplatin containing chemotherapy. 2)20 years old or older. 3)Performance status 0-2. 4)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients with the history of hypersensitivity or allergy for study drugs. 2)Patients who need and use antiemetic therapy during 48h before chemotherapy. 3)Patients with severe hepatic or renal dysfunction. 4)With convulsion. 5)Patients who need puncture to manage ascites. 6)Patients with complications inducing nausea and vomiting. 7)Patients with diabetes mellitus. 8)Patients who are judged to be inappropriate for this study.

Design outcomes

Primary

Measure	Time frame
Complete response rate during the 120 h after carboplatin administration.	—

Secondary

Measure	Time frame
Complete response rate during the acute, delayed phase. Complete control rate, safety.	—

Countries

Japan

Contacts

Public ContactKazuki Tanaka

Hamamatsu university school of medicine Second Division, Department of Internal Medicine

41231644@hama-med.ac.jp053-435-2263

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026