UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021361 |
|---|---|
| Receipt number | R000024635 |
| Scientific Title | The prophylactic effects of goshajinkigan on TC therapy-induced peripheral neuropathy |
| Date of disclosure of the study information | 2016/03/05 |
| Last modified on | 2024/09/10 09:29:01 |
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Basic information
Public title
The prophylactic effects of goshajinkigan on TC therapy-induced peripheral neuropathy
Acronym
The prophylactic effects of goshajinkigan
Scientific Title
The prophylactic effects of goshajinkigan on TC therapy-induced peripheral neuropathy
Scientific Title:Acronym
The prophylactic effects of goshajinkigan
Region
| Japan |
Condition
Condition
Ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prophylactic effect of goshajinkigan on TC therapy induced peripheral neuropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Maximum grade of neuropathy. Grade of neuropathy will be evaluated from the beginning of TC therapy to 1 month after the end of TC therapy.
Key secondary outcomes
Completion rate of chemotherapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
7.5g per day of goshajinkigan. 1week before chemotherapy to 1 month afterl end of chemotherapy.
Interventions/Control_2
7.5g per day of goshajinkigan. Onset of grade 2 peripheral neuropathy to 1 month afterl end of chemotherapy.
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
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
1) The patients diagnosed as ovarian cancer histologically
2) The patients who will receive TC therapy 6 times as first line chemotherapy
3) The patients with performance status 0-2.
4) The patients with normal laboratory data.
5) The patients who obtained written informed consent.
Key exclusion criteria
1) The patients who had received goshajinkigan.
2) The patients with severe peripheral neuropathy.
3) The patients with diabetic neuropathy,
4) The pregnant or breast feeding women.
5) The patients whom the doctor recognizes unsuitable subject.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Yokoyama |
Organization
Hirosaki University
Division name
Obstetrics and Gynecology
Zip code
036-8562
Address
5-Zaifu-cho, Hirosaki, Aomori, Japan
TEL
0172-39-5107
yokoyama@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Yokoyama |
Organization
Hirosaki University
Division name
Obstetrics and Gynecology
Zip code
036-8562
Address
5-Zaifu-cho, Hirosaki, Aomori, Japan
TEL
0172-39-5107
Homepage URL
yokoyama@hirosaki-u.ac.jp
Sponsor or person
Institute
Tohoku Gynecologic Oncology Unit
Institute
Department
Personal name
Funding Source
Organization
Tohoku Gynecologic Oncology Unit
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Hirosaki University Graduate School of Medicine
Address
5-Zaifu-cho, Hirosaki, Aomori, Japan
Tel
0172-33-5111
rinri@hirosaki-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
弘前大学医学部附属病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
55
Results
in analyzing the final data
Results date posted
| 2022 | Year | 09 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
in analyzing the final data
Participant flow
in analyzing the final data
Adverse events
in analyzing the final data
Outcome measures
in analyzing the final data
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 06 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 05 | Day |
Last modified on
| 2024 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024635
