Effectiveness of Acupuncture for Breast Cancer Related Lymphedema

Fourth Affiliated Hospital of Guangxi Medical University

Status: Unknown

Conditions: Breast Cancer; Acupuncture; Lymphedema

Treatments: Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02803736

PJK201690

Details and patient eligibility

About

This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in two groups: the real acupuncture group and the sham acupuncture group.

Full description

In the theory of Traditional Chinese Medicine (TCM), Breast Cancer Related Lymphedema (BCRL) is classified as "edema", and is considered to be caused by qi (chi) deficiency and blood stagnation. Acupuncture, as an ancient therapy in TCM, is thought to have the efficacy to stimulate the transformation of qi and drainage of dampness, and is widely used for various diseases including edema in China. Early clinical trials as well as our own clinical observation have demonstrated that acupuncture can ameliorate limb swelling and decrease lymphedema. However, no randomized placebo-controlled trial has been performed to evaluate this efficacy of acupuncture. Therefore, this study aimed to evaluate the safety and potential efficacy of acupuncture to treat chronic upper-limb lymphedema.

Enrollment: 150 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women who completed all primary and adjuvant treatments.
• age between 20 and 45.
• BMI between 18 and 28.
• unilateral lymphedema resulting from surgery for breast cancer.
• mild to moderate lymphedema, with 10% to 40% increase in volume compared to the unaffected arm based on perometry evaluation.
• with no evidence of recurrence.

Exclusion criteria

• bilateral lymphedema.
• history of bilateral axillary lymph node dissection.
• serious lymphedema, with over 40% increase in volume compared to the unaffected arm based on perometry evaluation.
• pregnant women.
• unable to adhere to the protocol or the treatment schedule.
• recurrent breast cancer or other malignancies.
• current use of chemotherapy or radiation.
• current use of diuretic drugs like Diosmin, or other investigational drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Real acupuncture group

Experimental group

Description:

Patients in the real acupuncture group will receive true acupuncture 3 times a week for 4 weeks (12 sessions). A standardized prescription of six acupuncture points is used unilaterally. Needles are inserted and manipulated manually until needling sensation (de qi) is obtained, and are retained for 20 minutes with manual manipulation at 10 minutes. Acupuncturists are trained to inquire about specific needle sensations when providing true acupuncture.

Treatment:

Device: acupuncture

Sham acupuncture group

Sham Comparator group

Description:

Patients in the sham acupuncture group will receive sham acupuncture 3 times a week for 4 weeks (12 sessions).

Treatment:

Device: acupuncture