UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023032
Receipt number R000026544
Scientific Title The exploration for the palliative efficacy of Hochu-ekkitou in genitourinary cancer patient
Date of disclosure of the study information 2016/07/20
Last modified on 2016/07/05 19:52:13

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Basic information

Public title

The exploration for the palliative efficacy of Hochu-ekkitou in genitourinary cancer patient

Acronym

HOPE Study

Scientific Title

The exploration for the palliative efficacy of Hochu-ekkitou in genitourinary cancer patient

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Satoshi Anai

Organization

Nara Medical University

Division name

Dept. of Urology

Zip code


Address

840 Shijo-Cho Kashihara-shi

TEL

0744-22-3051

Email

sanai@naramed-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Anai

Organization

Nara Medical University

Division name

Dept. of Urology

Zip code


Address

840 Shijo-Cho Kashihara-shi

TEL

0744-22-3051

Homepage URL


Email

sanai@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2016 Year 06 Month 08 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026544


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name