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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028094
Receipt No. R000032164
Scientific Title "Juzentaihoto" for fatigue of patients with solid cancer Observational study of feasibility and safety
Date of disclosure of the study information 2017/07/06
Last modified on 2019/07/08

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Basic information
Public title "Juzentaihoto" for fatigue of patients with solid cancer
Observational study of feasibility and safety
Acronym Study of feasibility and safety"Juzentaihoto" for fatigue of patients with solid cancer
Scientific Title "Juzentaihoto" for fatigue of patients with solid cancer
Observational study of feasibility and safety
Scientific Title:Acronym Study of feasibility and safety"Juzentaihoto" for fatigue of patients with solid cancer
Region
Japan

Condition
Condition Fatigue in solid cancer patients
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In order to verify the influence of juzentaihoto on solid cancer-affecting patients' NK cell function, juzentaihoto is administered to patients diagnosed as having indication for it after cancer incidence. NK cell function, NRS (Numerical Rating Scale) of fatigue and PS (performance status) after oral administration are examined. Then, we will study the correlation between the fatigue improvement effect of juzentaihoto and NK cell activity.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feasibility of juzentaihoto of cancer patients
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 juzentaihoto
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)Those who complain of fatigue in cancer patients 20 to 75 years old
2)Those who have been confirmed normal liver-kidney function, normal potassium values by blood test, and normal blood pressure in advance
3)Those who obtained document consent by the patient's free will after sufficient informed consent to participate in this research
Key exclusion criteria 1)Those who have taken Kampo formula within the last 2 weeks
2)Women who are pregnant or breast feeding
3)Person who has history of hypersensitivity to juzentaihoto
4)In case the research practitioner determines that it is inappropriate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Keiko
Middle name
Last name Ogawa
Organization Kanazawa University Hospital
Division name Department of Japanese-Traditional (Kampo) Medicine
Zip code 920-8641
Address 13-1 Takaramachi, Kanazawa-city, Ishikawa 920-8641
TEL 076-265-2918
Email okeiko@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Ogawa
Organization Kanazawa University Hospital
Division name Department of Japanese-Traditional (Kampo) Medicine
Zip code 920-8641
Address 13-1 Takaramachi, Kanazawa-city, Ishikawa 920-8641
TEL 076-265-2918
Homepage URL
Email okeiko@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Kanazawa University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kanazawa University Hospital
Address 13-1, Takara-machi, Kanazawa
Tel 0762652918
Email hpsangak@adm.kanazawa-u.ac.jp

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
2017 Year 07 Month 06 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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 06 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032164

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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