UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The exploration for the palliative efficacy of Hochu-ekkitou in genitourinary cancer patient
Title of the study (Brief title)	HOPE Study
Region	Japan

Condition
Condition	metastatic genitourinary cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The exploration for the palliative efficacy of Hochu-ekkitou in metastatic genitourinary cancer patient who were received at least one anti cancer therapeutic agent.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL Measuring IL-6, IL-1 beta, TNF alpha as the cachexia marker
Key secondary outcomes

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	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Metastatic genitourinary cancer patients who were received at least one anticancer agent 2)Patients planed the next new anticancer agents 3)Over 20-year old patients 4)ECOG PS 0-1 5)Patients who accept the enrollment in the study 6) Patients who have proper bone marrow, renal, and liver function
Key exclusion criteria	Patients who do not accept the enrollment in the study
Target sample size	50

Research contact person
Name of lead principal investigator	Satoshi Anai
Organization	Nara Medical University
Division name	Dept. of Urology
Address	840 Shijo-Cho Kashihara-shi
TEL	0744-22-3051
Email	sanai@naramed-u.ac.jp

Public contact
Name of contact person	Satoshi Anai
Organization	Nara Medical University
Division name	Dept. of Urology
Address	840 Shijo-Cho Kashihara-shi
TEL	0744-22-3051
Homepage URL
Email	sanai@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
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	Nara Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 08 Day
Anticipated trial start date	2016 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	QOL IL-6, IL-1 beta, TNF-alpha

Management information
Registered date	2016 Year 07 Month 05 Day
Last modified on	2016 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026544