Effectiveness of Acupuncture for Breast Cancer Related Lymphedema

Breast Cancer Clinical Trial

— Acupuncture  

Official title:

Effectiveness of Acupuncture for Breast Cancer Related Lymphedema

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02803736
• Other study ID #: PJK201690
• Status: Not yet recruiting
• Phase: N/A
• First received: June 14, 2016
• Last updated: November 21, 2016
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: November 2016
• Source: Fourth Affiliated Hospital of Guangxi Medical University
• Contact: Zheng Peng
• Phone: +86 772 3840144
• Email: 1371[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acupuncture
• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

Device:
• acupuncture
Acupuncture involves the insertion of extremely thin needles through skin at strategic points on human body. Many Western practitioners view the acupuncture as a device to stimulate nerves, muscles and connective tissue, and believe that it can increases blood flow.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Fourth Affiliated Hospital of Guangxi Medical University	Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou Maternity and Child Healthcare Hospital

References & Publications (1)

Andersen L, Højris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39(3):399-405. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Reduced Limb Volume Ratio	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.	Day 0 (baseline), Day 30(endpoint)	Yes
Secondary	Incidence of Adverse Event	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.	Day 0 (baseline), Day 30(endpoint)	Yes