Efficacy and Safety of Wuling San on Breast Cancer-related Lymphedema

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Wuling San on Breast Cancer-related Lymphedema

Conditions
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Breast Cancer, Lymphedema

Intervention / Treatment
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* Drug: Wuling San
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) age 20-40 with unilateral BCRL, stage I or II, BMI of 18-25 Volume difference ≥300 mL between the normal and lymphedematous upper extremity based on perometry evaluation No evidence of breast cancer recurrence At least 6 months postoperative from axillary lymph node dissection Exclusion Criteria: Bilateral lymphedema or stage III lymphedema History of bilateral axillary lymph node dissection Recent history of cellulitis in the affected extremity (within last 3 months) Recurrent breast cancer or other malignancy Current (within last month) use of chemotherapy for breast or other malignancy Current (within last 3 months) use of radiation for breast or other malignancy Recent (within last month) or current intensive MLD and/or short stretch bandage use Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months) Pregnant or nursing (lactating) women Patients that take drugs like diosmin at the time of enrollment, or within 30 days. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. Unable to comply with the protocol, measurement and follow-up schedule.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wuling San<br>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. | Drug: Wuling San<br>* Patients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation.<br>|
| Placebo Comparator: placebo<br>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. | Drug: placebo<br>* Patients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | number of participants with serious and non-serious adverse events | baseline and 2 months |