Tokyo, Oct. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059486) titled 'A prospective observational study on the safety and quality-of-life improvement effects of exercise therapy (Purple Edge Training) in breast cancer patients' on Oct. 27.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - BEYOND KAMPO Inc.
Condition:
Condition - breast cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Intervention:
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)
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 Size - 50
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068039
Disclaimer: Curated by HT Syndication.
