Study of antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with hematologic malignancy receiving highly emetogenic chemotherapy.
Not Applicable
Recruiting
- Conditions
- Hematologic malignancy
- Registration Number
- JPRN-UMIN000006375
- Lead Sponsor
- Department of Hematology and Oncology, Kurume University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patient has a serious hepatic insufficiency or renal failure 2) Patient has nausea or vomiting within 24 hours prior to chemotherapy 3) Patient has been treated with antiemetic agents within 24 hours prior to chemotherapy 4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting 5) Patient is pregnant or lactating woman, and woman who plans to become pregnant 6) Patient is currently treated with pimozide 7) Patient is judged inappropriate by the investigator as subject for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Proportion of patients with no emesis 2) Proportion of patients with no nausea and no more than mild nausea
- Secondary Outcome Measures
Name Time Method 1) Proportion of patients with complete response (no emesis and no use of rescue medication) 2) Proportion of patients with complete protection (no emesis, no use of rescue medication, and no more than mild nausea) 3) Distribution of incidences of nausea and vomiting 4) Time to first emetic episode and time to first use of rescue medication 5) Food ingestion 6) Change in body weight