Acupuncture, Breast Cancer, Lymphedema
Conditions
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.
Interventions
DEVICEacupuncture
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.
Sponsors
Liuzhou Hospital of Traditional Chinese Medicine
Liuzhou Maternity and Child Healthcare Hospital
Fourth Affiliated Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactZheng Peng
Outcome results
None listed