Acupuncture for Breast Cancer Related Lymphedema

Tianjin University of Traditional Chinese Medicine

Status: Unknown

Conditions: Breast Cancer Lymphedema

Treatments: Other: acupuncture; Other: sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04158193

2014CB543202-03

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical efficacy of acupuncture on chronic upper limb lymphedema in patients with breast cancer surgery

Enrollment: 60 estimated patients

Sex: Female

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.
• Stage II lymphedema according to the 2016 consensus by the international society of lymphology.
• Women aged 18 to 80 years
• Out-patients
• Estimated life expectancy > 6 months
• Upper extremity lymphedema is defined a more than 10% volume difference between the affected and unaffected arms

Exclusion criteria

• Bilateral breast cancer related lymphedema
• Tumor metastasis or recurrent patient
• Patients who is undergoing chemotherapy, radiation therapy or targeted therapy
• Taking diuretic
• Upper extremity lymphedema reached more than 80% volume difference between the affected and unaffected arms
• 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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60 participants in 2 patient groups

Acupuncture group

Experimental group

Description:

Subjects in the acupuncture group are given acupuncture treatment.

Treatment:

Other: acupuncture

Sham acupuncture control group

Experimental group

Description:

Subjects in the sham acupuncture control group are given non-acupoint shallow acupuncture.

Treatment:

Other: sham acupuncture