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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008021
Receipt No. 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

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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
Email 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
Email hkawajiri75@yahoo.co.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009421

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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