Who is sponsoring NCT02290470?

NCT02290470 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.

What condition does NCT02290470 study?

NCT02290470 studies Nausea, Vomiting.

What drugs are being tested in NCT02290470?

Interventions: Olanzapine, Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine.

What is the status of NCT02290470?

NCT02290470 is currently UNKNOWN.

Last reviewed 2014-11-11 · How we verify

Olanzapine for the Prevention of Delayed Nausea and Vomiting in Patients With Gynecologic Cancers Receiving Carboplatin and Paclitaxel-based Chemotherapy and Guideline-directed Prophylactic Anti-emetics

NCT02290470 Phase 2 UNKNOWN

This randomized, pilot study explores the activity of olanzapine with or without delayed dexamethasone for the prevention of delayed nausea and vomiting in women with gynecologic cancer receiving the combination of carboplatin and paclitaxel. Women treated with this regimen are particularly susceptible to chemotherapy-induced nausea and vomiting. Given anti-emetic prophylaxis with olanzapine may increase the control of delayed symptoms in women receiving carboplatin and paclitaxel.

Details

Lead sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Phase	Phase 2
Status	UNKNOWN
Enrolment	81
Start date	2014-04
Completion	2015-11

Conditions

Nausea
Vomiting

Interventions

Olanzapine
Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine

Primary outcomes

Complete Protection — days 2-5 post-chemotherapy
Proportion of patients achieving delayed Complete Protection, defined as no vomiting, no rescue anti-emetics, and no more than mild nausea measured by the Nausea and Vomiting Daily Diary/Questionnaire.

Countries

Italy