Warm Acupuncture for Breast Cancer Related Lymphedema

Tianjin University of Traditional Chinese Medicine

Status: Completed

Conditions: Breast Cancer Lymphedema

Treatments: Other: local distribution points association; Other: local-distal points association

Study type: Interventional

Funder types: Other

Identifiers

NCT03373474

2014CB543202-02

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 3 patient groups

local distribution points association

Experimental group

Description:

Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.

Treatment:

Other: local distribution points association

local-distal points association

Experimental group

Description:

Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.

Treatment:

Other: local-distal points association

waiting-list

No Intervention group

Description:

Patients in the waiting-list group will not receive any acupuncture treatment during the study. However, for ethical consideration, 20 free acupuncture treatments will be offered after the study is completed.