Clinical trial NCT02803736: Effectiveness of Acupuncture for Breast Cancer Related Lymphedema
Official title: Effectiveness of Acupuncture for Breast Cancer Related Lymphedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lymphedema
Acupuncture
Lead sponsor: Fourth Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
Collaborators: name: Liuzhou Hospital of Traditional Chinese Medicine
name: Liuzhou Maternity and Child Healthcare Hospital
First posted: 2016-06-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Reduced Limb Volume Ratio
timeFrame: Day 0 (baseline), Day 30(endpoint)
Secondary outcomes:
measure: Incidence of Adverse Event
timeFrame: Day 0 (baseline), Day 30(endpoint)
Other outcomes:
Locations:
Study officials:
affiliation: Guangxi Medical University Institutional Review Board
name: Xiangcheng Wei
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen L, Hojris 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. doi: 10.1080/028418600750013186.
citation: Zhu H, Li J, Peng Z, Huang Y, Lv X, Song L, Zhou G, Lin S, Chen J, He B, Qin F, Liu X, Dai M, Zou Y, Dai S. Effectiveness of acupuncture for breast cancer related lymphedema: protocol for a single-blind, sham-controlled, randomized, multicenter trial. BMC Complement Altern Med. 2017 Sep 21;17(1):467. doi: 10.1186/s12906-017-1980-0.