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| Name | Class |
|---|---|
| Liuzhou Hospital of Traditional Chinese Medicine | OTHER |
| Liuzhou Maternity and Child Healthcare Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real acupuncture group | Experimental | 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. |
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| Sham acupuncture group | Sham Comparator | Patients in the sham acupuncture group will receive sham acupuncture 3 times a week for 4 weeks (12 sessions). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Peng | Contact | +86 772 3840144 | 1371@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangcheng Wei | Guangxi Medical University Institutional Review Board | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10987238 | Background | 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. | |
| 28934950 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |