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| Name | Class |
|---|---|
| Liuzhou Maternity and Child Healthcare Hospital | OTHER |
| Liuzhou Hospital of Traditional Chinese Medicine | OTHER |
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The purpose of this study is to assess the efficacy and safety of Wuling San, a traditional Chinese medicine, in reducing arm volume excess in women with stage I-II breast cancer related unilateral lymphedema.
The investigators will aim to enroll 200 female adult patients (aged between 20 and 40 years) of all ethnicities/races, who have been referred to the Fourth Affiliated Hospital of Guangxi Medical University for breast cancer related unilateral lymphedema. The investigators will be using a standardized data collection form in this study, where standard of care will be practiced and the patients are not placed at additional risk from participating in this study. However, as the investigators are collecting data prospectively, all participants will sign consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wuling San | Experimental | This is a double-blinded, randomized placebo-controlled, multi-center clinic trial, using before and after treatment measurements. A total of 200 clinical diagnosed BCRL participants with affected arm circumference 10-40% larger than unaffected arm, are randomly allocated to two groups: the Wuling San group or the placebo group, where the intervention group administers Wuling San, at a dosage of 1g/kg, twice a day for six weeks. The primary outcome measurement will be the percentage of limb volume changes measured by perometry. |
|
| placebo | Placebo Comparator | A total of 200 clinical diagnosed BCRL participants with affected arm circumference 10-40% larger than unaffected arm, are randomly allocated to two groups: the Wuling San group or the placebo group, where the placebo group administers a placebo powder, at a dosage of 1g/kg, twice a day for six weeks. The primary outcome measurement will be the percentage of limb volume changes measured by perometry. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wuling San | Drug | Patients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| volume changes % measured by perometry | Volume changes in the arm after the therapy will be calculated using the methods established by Anderson et al (2000). Briefly, the difference in volume measurements between the normal and lymphedematous arms at baseline will be compared to the volume differential after drug treatment (i.e volume excess) using the following formula: Change in absolute edema=(Vo-Vc)B-(Vo-Vc)3 months/(Vo-Vc)B Change in ln ratio=ln (Vo/Vc)B-ln (Vo/Vc)3 months. Vo is the volume of the lymphedema arm. Vc is the volume of the contralateral arm. Andersen, L., Højris, I., Erlandsen, M., & Andersen, J. (2000). Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage: a randomized study[J]. Acta Oncologica, 2000, 39(3): 399-405. | baseline and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | number of participants with serious and non-serious adverse events | baseline and 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Peng | Contact | +86 07723815334 | labstar@qq.com | |
| Xiangcheng Wei | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Xiangcheng Wei | Guangxi Medical University Institutional Review Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liuzhou Hospital of Traditional Chinese Medicine | Recruiting | Liuzhou | Guangxi | 545000 | China |
| 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. | |
| 27986736 | Derived | Zhu H, Peng Z, Dai M, Zou Y, Qin F, Chen J, Song L, He B, Lv X, Dai S. Efficacy and safety of Wuling San for treatment of breast-cancer-related upper extremity lymphoedema: study protocol for a pilot trial. BMJ Open. 2016 Dec 16;6(12):e012515. doi: 10.1136/bmjopen-2016-012515. |
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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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| placebo | Drug | Patients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation. |
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| Liuzhou Maternity and Child Healthcare Hospital | Recruiting | Liuzhou | Guangxi | 545000 | China |
|
| The Fourth Affiliated Hospital of Guangxi Medical University | Recruiting | Liuzhou | Guangxi | 545000 | China |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |