UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045874 |
|---|---|
| Receipt number | R000051645 |
| Scientific Title | Evaluation after taking Ninjinyoeito in the treatment of post-treatment malaise associated with gynecological cancer: an prospective observational study |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2025/10/29 17:11:28 |
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Basic information
Public title
Observation of the effect of Ninjinyoeito on post-treatment malaise in gynecological cancer
Acronym
Observation of the effect of Ninjinyoeito on post-treatment malaise in gynecological cancer
Scientific Title
Evaluation after taking Ninjinyoeito in the treatment of post-treatment malaise associated with gynecological cancer: an prospective observational study
Scientific Title:Acronym
Evaluation after taking Ninjinyoeito in the treatment of post-treatment malaise associated with gynecological cancer: an prospective observational study
Region
| Japan |
Condition
Condition
Malaise
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the improvement of post-treatment malaise in gynecological cancer patients by administration of Ninjinyoeito
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change, rate of change of the CFS score 12 weeks after the dosage start
Key secondary outcomes
1) Amount and rate of change in evaluation forms (ECOG-PS, HADS, AIS, The FAACT A/CS)
2) Amount and rate of change of laboratory values measured in routine clinical care at the time of patient visit
3) Amount and rate of change in oxidative stress and antioxidant capacity
4) Associations between insomnia, loss of appetite, and anxiety and improvement in fatigue
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) The patients complaining of fatigue and malaise
2 ) The patients who have completed gynecological cancer (cervical cancer, uterine cancer, ovarian cancer) treatment (surgical operation (pelvic lymph node dissection), chemotherapy, radiotherapy) for more than one month.
3) The patients who were prescribed with Ninjinyoeito under a doctor's diagnosis
4) The patients with documented consent
Key exclusion criteria
1) The patients who are regularly using other Kampo medicine.
2) The patients with stage IV malignancy
3) The patients with PS(Performance Status) of 3 or 4
4) The patients considered to have a prognosis of less than six months
5) The patients with the experience an allergy after taking any Kampo medicine
6) The patients with a remarkable digestive organ symptom
7) The patients diagnosed with major depressive disorder and undergoing prescription adjustment
8) The patients with aldosteronism, myopathy, hypokalemia, or suspected
9) The patients with hepatic dysfunction (AST>80 IU/L or ALT>80 IU/L)
10) The patients who were judged not to be included by researchers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University School of Medicine
Division name
Center for Kampo Medicine
Zip code
160-8582
Address
SHINANOMACHI 35, SHINJYUKU-KU, TOKYO JAPAN
TEL
03-5366-3824
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Horiba |
Organization
Keio University School of Medicine
Division name
Center for Kampo Medicine
Zip code
160-8582
Address
SHINANOMACHI 35, SHINJYUKU-KU, TOKYO JAPAN
TEL
03-5366-3824
Homepage URL
mannta217@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Center for Kampo Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Keio University School of Medicine
Address
SHINANOMACHI 35, SHINJYUKU-KU, TOKYO JAPAN 160-8582
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.keio-kampo.jp/ja_2/page07.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.keio-kampo.jp/ja_2/page07.html
Number of participants that the trial has enrolled
23
Results
A notable decrease in the total CFS score was observed after 12 weeks of treatment, indicating a reduction in fatigue. No significant changes in the FAACT A/CS scores were observed after 12 weeks of administration. A significant decrease in the AIS scores was noted after 12 weeks of treatment, suggesting an improvement in insomnia. Significant reductions in anxiety and depression scores were observed after 12 weeks of treatment.
Results date posted
| 2025 | Year | 10 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 25 enrolled participants, two were excluded, and 23 were selected for the final analysis (Fig 1). The demographic background and medication adherence of the 23 participants included in the final analysis are summarized. Among the 23 individuals, cervical cancer was the most prevalent, accounting for 14 (60.9%) patients, followed by endometrial cancer (five [17.4%]) and ovarian cancer (four [21.7%]). Regarding cancer stage, of the 20 patients with stage I cancer, ten (43.5%) had stage IA, seven (30.4%) had stage IB, and three (13.0%) had stage IC. Additionally, two patients (8.7%) had stage II and one (4.3%) had stage III cancer.
Before inclusion in the current study, six (26.0%) patients had undergone chemotherapy. Of these, five received paclitaxel/carboplatin therapy and one received cisplatin therapy. In addition, three (13.0%) patients had undergone radiotherapy before the commencement of this study.
Adherence to the prescribed medication regimen was categorized based on patients, but nobody was excluded due to the poor adherence.
Participant flow
The patient received care for gynecological cancer at Keio University Hospital from August 2021 to September 2023 and the patient has undergone surgical treatment (n=152). More than one month after the end of treatment, patients who complained of fatigue and malaise were prescribed Kracie ninjinyoeito extract fine granules (7.5 g/day, twice a day) (n=25). Breast cancer recurrence (n=1) and withdrawal from participation (n=1) were excluded. A total of 23 participants were analyzed.
Adverse events
No adverse events were observed.
Outcome measures
The primary outcome was the change in the degree of fatigue assessed using the Chalder Fatigue Scale (CFS). The secondary outcomes included the magnitude and rate of change from before to after ninjinyoeito administration using the following measures: appetite score according to the Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT A/CS) questionnaire (maximum, 48), sleep score according to the Athens Insomnia Scale (AIS) (maximum, 24), and anxiety and depression scores based on the Hospital Anxiety and Depression Scale (HADS) (maximum, 42). The HADS scores were derived by calculating the total scores of odd-numbered items for anxiety and even-numbered items for depression. An increase in the FAACT A/CS total score indicates an improvement in appetite loss, whereas a decrease in the AIS and HADS scores indicates amelioration of insomnia, anxiety, and depression. We performed additional tests using residual blood samples to assess oxidative stress (diacron reactive oxygen metabolite test) and antioxidant capacity (biological antioxidant potential test).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 14 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 29 | Day |
Other
Other related information
CFS
ECOG-PS
HADS
AIS
The FAACT A/CS questionnaire
Management information
Registered date
| 2021 | Year | 10 | Month | 26 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051645
