UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008021 |
|---|---|
| Receipt number | R000009421 |
| Scientific Title | A randomized clinical trial on the efficacy of Goshajinkigan or carbon dioxide rich water bathing on reducing Paclitaxel-induced peripheral neuropathy during neoadjuvant chemotherapy to breast cancer |
| Date of disclosure of the study information | 2012/05/23 |
| Last modified on | 2013/11/29 11:59:29 |
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Basic information
Public title
A randomized clinical trial on the efficacy of Goshajinkigan or carbon dioxide rich water bathing on reducing Paclitaxel-induced peripheral neuropathy during neoadjuvant chemotherapy to breast cancer
Acronym
A randomized clinical trial on the efficacy of Goshajinkigan or carbon dioxide rich water bathing on reducing Paclitaxel-induced peripheral neuropathy during neoadjuvant chemotherapy to breast cancer
Scientific Title
A randomized clinical trial on the efficacy of Goshajinkigan or carbon dioxide rich water bathing on reducing Paclitaxel-induced peripheral neuropathy during neoadjuvant chemotherapy to breast cancer
Scientific Title:Acronym
A randomized clinical trial on the efficacy of Goshajinkigan or carbon dioxide rich water bathing on reducing Paclitaxel-induced peripheral neuropathy during neoadjuvant chemotherapy to breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Recently, Paclitaxel is essential anti-cancer drug for breast cancer. However, although it often occur peripheral neuropathy as adverse event, the supportive therapy is not established. Therefore, we planned a randomized clinical trial on the efficacy of Goshajinkigan or carbon dioxide rich water bathing on reducing Paclitaxel-induced peripheral neuropathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
reducing neuropathy
Key secondary outcomes
adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Goshajinkigan
Interventions/Control_2
carbon dioxide rich water bathing
Interventions/Control_3
control
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1)Age:18 to 74
2)Patients with primary breast cancer who are scheduled to receive FEC100 followed by weekly Paclitaxel as neoadjuvant chemotherapy
3)Written informed consent
Key exclusion criteria
1)Diabetes Mellitus, peripheral neuropathy
2)having prior allergy of skin
3)Physician's decision of inappropriateness
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemi Kawajiri |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3838
hkawajiri75@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidemi Kawajiri |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3838
Homepage URL
hkawajiri75@yahoo.co.jp
Sponsor or person
Institute
Osaka City University Graduate School of 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
Address
Tel
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
| 2012 | Year | 05 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | 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
| 2012 | Year | 05 | Month | 23 | Day |
Last modified on
| 2013 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009421
