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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021361
Receipt No. 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 2020/09/08

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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
Obsterics 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
Email 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
Email yokoyama@hirosaki-u.ac.jp

Sponsor
Institute Tohoku Gynecologic Oncology Unit
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 55
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 No longer recruiting
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
2020 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024635

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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