Status:
COMPLETED
Warm Acupuncture for Breast Cancer Related Lymphedema
Lead Sponsor:
Tianjin University of Traditional Chinese Medicine
Collaborating Sponsors:
National Basic Research Program, China
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Breast Cancer Lymphedema
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to clarify whether local-distal point association is more effective than local point association by warm acupuncture in the management of breast cancer related lymphedema.
Eligibility Criteria
Inclusion
- At least 6 months after breast cancer surgery and presents with persistent breast cancer related upper extremity lymphedema for at least 3 months. Upper extremity lymphedema is defined as more than 2cm circumference difference or 5% volume difference between the affected and unaffected arms.
- Stage II or III lymphedema according to the 2016 consensus by the international society of lymphology.
- Karnofsky Performance Score (KPS) ≥ 70
- Men or women aged 18 to 80 years
- Out-patients
- Estimated life expectancy \> 6 months
Exclusion
- Bilateral breast cancer related lymphedema
- Taking diuretic
- History of primary lymphedema
- A diagnosis of severe heart, liver, kidney or hematologic disease
- Edema caused by upper extremity disability or other conditions such as heart failure, kidney disease or malnutrition
- Have hypoproteinemia
- Inflammation, scar, or trauma at the site of operation, or other active skin infections
- Unable to self-care, had a history of psychological disorders, or unable to communicate
- Received lymphedema treatment within the past 1 month
- Pregnancy or breastfeeding
- The presence of electronic medical device implants
- Deny to sign the informed written consent, or unwilling to conform to randomization
- Participation in other clinical trials during the study period
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2020
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03373474
Start Date
January 18 2018
End Date
December 26 2020
Last Update
May 6 2021
Active Locations (1)
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1
Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China