Randomized phase II study of rikkunshito on chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy for lung cancer (HOT1402)
Phase 2
- Conditions
- ung Cancer
- Registration Number
- JPRN-UMIN000014239
- Lead Sponsor
- Hokkaido Lung Cancer Clinical Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
Not provided
Exclusion Criteria
1)Drug allergy unfit for the study 2)Active infectious diseases 3)Severe complications (severe cardiac diseases, cerebrovascular diseases, active peptic ulcer, poorly controlled diabetes mellitus, clinically problematic, psycho-neurologic diseases) 4)Symptomatic brain metastasis 5)Active concomitant malignancy 6)Women who is lactating or pregnant or man who hope the pregnancy of the partner 7)Previous Rikkunshito therapy 8)Ineligible judgment by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response (no emesis, no retching, no rescue medication) rate in overall phase
- Secondary Outcome Measures
Name Time Method Completer response (no emesis, no retching, no rescue medication) rate in acute/delayed phase, Complete protection [no emesis, no retching, no rescue medication, no significant nausea (VAS < 25mm)] rate in acute/delayed/overall phase, Total protection [(no emesis, no retching, no rescue medication, no nausea(VAS < 5mm)) rate in acute/delayed/overall phase, No emesis rate in acute/delayed/overall phase, No rescue medication rate in acute/delayed/overall phase, No significant nausea (VAS <25mm) rate in acute/delayed/overall phase, No nausea (VAS < 5mm) rate in acute/delayed/overall phase, Dietary intake in overall phase, Safety