A phase II study of palonosetron to prevent nausea and vomiting induced by chemotherapy in haematological malignancies.

Phase 2

• Conditions: haematological malignancies

• Registration Number: JPRN-UMIN000010746
• Lead Sponsor: Hematology, Department of Medicine Kitasato University, School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-01
• Study Completion: 2014-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1) With other severe diseases 2) No double cancer 3) Hypersensitivity for palonosetron 4) History of palonosetron use 5) History of receiving high emetic risk chemotherapy classified according to Antiemetic Guideline for Patients with Malignancies in Japan 6) With nausea and/or vomiting 7) Require continuous administration of systemic steroids 8) Not appropriate for the study at the physician's assessment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Control Rate in overall phase(0-120 hours after chemotherapy)

Secondary Outcome Measures

Name	Time	Method
Complete Response Rate in overall phase(0-120 hours after chemotherapy) The proportion of patients without nausea in overall, acute and delayed phase Complete Control Rate in acute phase(0-24 hours after chemotherapy) Complete Control Rate in delayed phase(25-120 hours after chemotherapy) Complete Response Rate in acute phase(0-24 hours after chemotherapy) Complete Response Rate in delayed phase(25-120 hours after chemotherapy) The proportion of patients without nausea in acute phase The proportion of patients without nausea in delayed phase