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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Patients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation.
Patients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation.
Liuzhou Hospital of Traditional Chinese Medicine
Liuzhou, Guangxi, China
RECRUITINGLiuzhou Maternity and Child Healthcare Hospital
Liuzhou, Guangxi, China
RECRUITINGThe Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi, China
RECRUITINGvolume 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.
Time frame: baseline and 2 months
adverse events
number of participants with serious and non-serious adverse events
Time frame: baseline and 2 months
Xiangcheng Wei
CONTACT
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