Randomized phase II study of rikkunshito on chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy for lung cancer (HOT1402)

Randomized phase II study of rikkunshito on chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy for lung cancer (HOT1402) - Phase II study of rikkunshito on CINV in patients receiving HEC for lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014239

Enrollment

Registered

2014-06-13

Start date

2014-06-13

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

Lung Cancer

Interventions

Standard antiemetic therapy recommended by each of the guidelines [National Comprehensive Cancer Network(NCCN), European Society for Medical Oncology, American Society of Clinical Oncology(ASCO), Japa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Age 20 or older 2)Histological or cytological confirmation of lung cancer 3)Cisplatin containing chemotherapy regimen 4)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 5)Laboratory test results within these ranges 1.White blood cell count=>3,000/ul or neutrophils=>1,500/ul 2.Hemoglobin=>9.0g/dl 3.Platelets=>100,000/ul 4.Total bilirubin<=1.5mg/dL 5.AST and ALT=<100IU/L 6.Creatinine=<1.5mg/dl 7.Coreatinin clearance=>60mL/min 8.PaO2=>60Torr or SpO2=>92% 6)A life expectancy=>2 months 7)Written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Complete response (no emesis, no retching, no rescue medication) rate in overall phase	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactToshiyuki Harada, MD, PhD

Japan Community Health care Organization (JCHO) Hokkaido Hospital Center for Respiratory Diseases

harada-toshiyuki@hokkaido.jcho.go.jp011-831-5151

Outcome results

None listed

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