UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042462 |
|---|---|
| Receipt number | 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 | 2021/11/27 07:55:02 |
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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
10years late brest cancer recurrence rate
Key secondary outcomes
White blood cell and lynphocyte Th1/Th2 CA
15-3 and Treg 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
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
miz323@poplar.ocn.ne.jp
Sponsor or person
Institute
mizushima clinic
Institute
Department
Personal name
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
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
Jornal of Clinical Research and Medicine
Publication of results
Published
Result
URL related to results and publications
Journal of Clinical Research and Medicine
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 10years .It was
Th1/Th2 21.5/5.0 before non-treatment in
the acupuncture group but Th1/Th2 20.6/5.2 become after10years. The relapse rate
after 10years 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
| 2021 | Year | 06 | Month | 04 | Day |
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 Treg58.0 become
after 10years 30.2/3.0 Treg8.6.The relapse
rate stage1 0% stage2/4 21.4%.non-acupunctu-re treatment TH1/TH2 21.5/5.0 Treg55.2
10years after 20.6/5.2 Treg52.4.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
TH1/TH2 Treg relapse rate significant difference
Management information
Registered date
| 2020 | Year | 11 | Month | 16 | Day |
Last modified on
| 2021 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048017
