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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042462
Receipt No. R000048017
Scientific Title Study of the recurrence rate in the treatment in use crowd of acupuncture and moxibution and non-in use crowd of breast cancer post-operatively
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/15

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Basic information
Public title The influence teatment of acupuncture and moxibution gives it to breast cancer postoperation immunity
Acronym Treatment of acupuncture and moxibution and immunity
Scientific Title Study of the recurrence rate in the treatment in use crowd of acupuncture and moxibution and non-in use crowd of breast cancer post-operatively
Scientific Title:Acronym The recurrence rate in the treatment acupuncture and moxibution of breast cancer post-operatively
Region
Japan

Condition
Condition After the breast cancer operation under chemoterapy
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Does treatment of acupuncuture and moxibution have an influence on the breat cancer post-operation immunity
Basic objectives2 Others
Basic objectives -Others Does acupuncture and moxibution treatment influence a recurrense rate after the breast cancer operation
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 5 years late brest cancer recurrence rate
Key secondary outcomes White blood cell and lynphocyte Th1/Th2 CA
15-3 measure every 3 months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Acupuncture snd moxibution treatment per 2weeks under cemoterapy of breast cancer post-operative
Interventions/Control_2 Under chemoterapy of breast cancer post-operative not do acupuncture and moxibution terapy
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 During postoperation cehmoterapy for breast cancer
Key exclusion criteria Cases in which informed consent could not be obtained
Target sample size 50

Research contact person
Name of lead principal investigator
1st name hideko
Middle name
Last name miyajima
Organization mizushima clinic oriental medicine institute
Division name acupuncture and moxibution bureau
Zip code 385-0052
Address hara567-7 saku-shi nagano perf. japan
TEL 0267-64-5339
Email miz323@poplar.ocn.ne.jp

Public contact
Name of contact person
1st name takeo
Middle name
Last name mizushima
Organization mizushima clinic
Division name medical office
Zip code 385-0052
Address hara567-7 saku-shi nagano pref.
TEL 0256-63-5353
Homepage URL
Email miz323@poplar.ocn.ne.jp

Sponsor
Institute mizushima clinic
Institute
Department

Funding Source
Organization mizushima clinic
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization mizushima clinic
Address hara567-7 saku-shi nagano pref.japan
Tel 0267-63-5353
Email miz323@poplar.ocn.ne.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 水嶋クリニック 東洋医学研究所

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 16 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 51
Results It was Th1/Th2 20.4/4.9 before treatment
in the acupuncture group ,but Th1/Th2 30.2/3.0 after treatment 5years .It was
Th1/Th2 21.5/5.0 before non-treatment in
the acupuncture group but Th1/Th2 20.6/5.2 become after 5years. The relapse rate
after 5years did not accept significant
difference in stage1 (both relapse rate0%), but acupuncture treatment group in
stage2-4 was dominant relapse rate decreased (rate 21.4%) for non-treatment group
(rate 66.6%)
Results date posted
2020 Year 11 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics acupuncture and moxibution treatment 30cases of breast cancer post-operatively stage1 16cases averg.age63y.o. staji 2~4 14cases averg.age 60y.o.
non- acupuncture treatment 21cases averg.age 66y.O. stage2~4 21cases averg.age 59 y.o.
Participant flow acupuncture and moxibution treatment groupand non-treatment group no dropout cases
Adverse events acupuncture and moxibution treatment group and non-treatment group no adverse event.
Outcome measures acupuncture and moxibution treatment for
breast cancer post-operativily is first
level TH1/TH2 20.4/4.9 become after 5years 30.2/3.0The relapse rate stage1 0% stage2~4 21.4%.non-acupuncture treatment TH1/TH2 21./5.0 5years after 20.6/5.2.The relapse rate stage1 0% and stage2~4 66.6%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2003 Year 04 Month 01 Day
Date of IRB
2003 Year 01 Month 16 Day
Anticipated trial start date
2003 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2020 Year 11 Month 01 Day

Other
Other related information currently being analyzed

Management information
Registered date
2020 Year 11 Month 16 Day
Last modified on
2020 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048017

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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