Effectiveness of Acupuncture for Breast Cancer Related Lymphedema

Not Applicable

• Conditions: Lymphedema; Breast Cancer; Acupuncture
• Interventions: Device: acupuncture

• Registration Number: NCT02803736
• Lead Sponsor: Fourth Affiliated Hospital of Guangxi Medical University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-23
• Study Start: 2016-12
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Absolute Reduced Limb Volume Ratio	Day 0 (baseline), Day 30(endpoint)	Data of the absolute limb volume will be collected before the treatment (volume at baseline, B) and after the treatment (volume after therapy, A) for every participant. VL is the volume of the affected arm with lymphedema, and VC is the volume of the contralateral arm. Then, The ARLVR will be calculated using the following formula: ARLVR (%) = (VL-Vc)B-( VL-Vc)A/( VL-Vc)B ×100%.; The arm measurement will be conducted using perometer. This method is inspired by the method established by Anderson et al.

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Event	Day 0 (baseline), Day 30(endpoint)	Every adverse event during the treatment will be recorded, unless it is confirmed otherwise, whereas those occurs after the treatment will not be calculate unless it is confirmed.