UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059486 |
|---|---|
| Receipt number | R000068039 |
| Scientific Title | A prospective observational study on the safety and quality-of-life improvement effects of exercise therapy (Purple Edge Training) in breast cancer patients |
| Date of disclosure of the study information | 2025/10/27 |
| Last modified on | 2025/10/21 13:23:48 |
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Basic information
Public title
A prospective observational study on the safety and quality-of-life improvement effects of exercise therapy (Purple Edge Training) in breast cancer patients
Acronym
Health improvement effects of Purple Edge Training in breast cancer patients
Scientific Title
A prospective observational study on the safety and quality-of-life improvement effects of exercise therapy (Purple Edge Training) in breast cancer patients
Scientific Title:Acronym
A prospective observational study on the safety and quality-of-life improvement effects of exercise therapy (Purple Edge Training) in breast cancer patients
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This exploratory study will evaluate the safety and potential quality-of-life benefits of once-weekly Purple Edge training over a 48-week period in patients receiving or having completed treatment for breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety (incidence of adverse events), changes in bone mineral density, maximal voluntary force production, and Profile of Mood States 2nd edition (POMS2) score
Key secondary outcomes
Changes in breast cancer-specific QOL, sleep (AIS), etc.
(If symptomatic)
Pain (VAS), shoulder range of motion, lymphedema
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
bioDensity: High-intensity, low-frequency, osteogenic loading (approximately 5 minutes)
Power Plate: Whole-body vibration training (approximately 5 minutes)
NEURONIC/RED LIGHT: Light therapy (about 10 minutes)
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
Female (20 years of age or older)
Patients with breast cancer who have undergone surgery, are undergoing treatment (ongoing or scheduled chemotherapy or endocrine therapy),or are in remission
Patients who are able to visit the center and exercise on their own
Patients who have received permission from their doctor to exercise
Patients who have voluntarily agreed to participate in the study
Key exclusion criteria
Patients with conditions that contraindicate exercise, such as metastasis
Patients who are deemed inappropriate by a doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Nagashima |
Organization
BEYOND KAMPO Inc.
Division name
Representative Director
Zip code
781-0087
Address
1-16 Minamikubo, Kochi City, Kochi Prefecture
TEL
090-4803-2888
beyondkampo@gmail.com
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Takasaki |
Organization
BEYOND KAMPO Inc.
Division name
Director
Zip code
781-0087
Address
1-16 Minamikubo, Kochi City, Kochi
TEL
090-4803-2888
Homepage URL
beyondkampo@gmail.com
Sponsor or person
Institute
BEYOND KAMPO Inc.
Institute
Department
Personal name
Keiko Nagashima
Funding Source
Organization
BEYOND KAMPO Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Kochi Medical School Hospital
Name of secondary funder(s)
Kochi Prefecture Industrial Promotion Department Industrial Innovation Division
IRB Contact (For public release)
Organization
Ethics Committee of Hattori Gastroenterology Clinic
Address
2-12-35 Shinmachi, Chuo-ku, Kumamoto-shi, Kumamoto, Japan
Tel
096-325-2300
sakuraiko@jcom.zaq.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068039
