UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study of rikkunshito on chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy for lung cancer (HOT1402)
Title of the study (Brief title)	Phase II study of rikkunshito on CINV in patients receiving HEC for lung cancer
Region	Japan

Condition
Condition	Lung Cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Rikkunshito on chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy for lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Complete response (no emesis, no retching, no rescue medication) rate in overall phase
Key secondary outcomes	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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), Japanese Society of Clinical Oncology(JSCO)]
Interventions/Control_2	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), Japanese Society of Clinical Oncology(JSCO)] with Rikkunsito
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	58

Research contact person
Name of lead principal investigator	Toshiyuki Harada, MD, PhD
Organization	Japan Community Health care Organization (JCHO) Hokkaido Hospital
Division name	Center for Respiratory Diseases
Address	1-8-3-18, Nakanoshima, Toyohira-ku, Sapporo 062-8618, Japan
TEL	011-831-5151
Email	harada-toshiyuki@hokkaido.jcho.go.jp

Public contact
Name of contact person	Toshiyuki Harada, MD, PhD
Organization	Japan Community Health care Organization (JCHO) Hokkaido Hospital
Division name	Center for Respiratory Diseases
Address	1-8-3-18, Nakanoshima, Toyohira-ku, Sapporo 062-8618, Japan
TEL	011-831-5151
Homepage URL
Email	harada-toshiyuki@hokkaido.jcho.go.jp

Sponsor
Institute	Hokkaido Lung Cancer Clinical Study Group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北海道肺癌臨床研究会関連施設、参加施設

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 13 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 05 Month 23 Day
Anticipated trial start date	2014 Year 06 Month 13 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry	2016 Year 07 Month 31 Day
Date trial data considered complete	2016 Year 07 Month 31 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 12 Day
Last modified on	2016 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016586