UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028094 |
|---|---|
| Receipt number | 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 | 2026/03/06 13:54:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
okeiko@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
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
https://doi.org/10.3390/ph18111658
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/1424-8247/18/11/1658
Number of participants that the trial has enrolled
10
Results
Efficacy
Within the constraints of a small, non-randomized cohort without placebo administration, Juzentaihoto was suggested to selectively modulate Fas-mediated lymphocyte apoptosis without promoting tumor immune evasion.
Safety
Juzentaihoto is an already approved Kampo medicine. No serious adverse events occurred in this trial, confirming its safety.
Results date posted
| 2026 | Year | 03 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
Kampo group
Male 4 (40%)
Female 6 (60%)
Diagnosis
Head and Neck Cancer 4 (40%)
Laryngeal cancer 2 (20%)
Hypopharyngeal cancer 1 (10%)
Oropharyngeal cancer 1 (10%)
Parotid gland cancer 1 (10%)
Breast cancer 6 (60%)
Adverse effects (Kampo group) 0 (0%)
Chemotherapy (Kampo group) 6 (60%)
Radiotherapy (Kampo group) 7 (70%)
Healthy Group
Male 3 (30%)
Female 7 (70%)
Participant flow
To evaluate the effects of Juzentaihoto (JTT) on NK-cell phenotypes, peripheral blood
samples from ten cancer patients and ten healthy volunteers were analyzed at baseline (Day
0) and after 14 days of JTT treatment. Flow cytometry was used to assess NK-cell subsets
(CD56 dim and CD56 bright) and surface expression of activation and adhesion markers.
Adverse events
None
Outcome measures
Clinical study: For flow cytometry data, the expression levels of immune markers (e.g., CD95, CD161, NKp46) before and after treatment were compared using two-tailed paired t-tests.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
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
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032164
