Breast Cancer, Lymphedema
Conditions
Brief summary
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
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.
Interventions
DRUGWuling San
Patients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation.
DRUGplacebo
Patients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation.
Sponsors
Liuzhou Maternity and Child Healthcare Hospital
Liuzhou Hospital of Traditional Chinese Medicine
Fourth Affiliated Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| volume changes % measured by perometry | baseline and 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | baseline and 2 months | number of participants with serious and non-serious adverse events |
Countries
China
Contacts
Primary ContactZheng Peng
Backup ContactXiangcheng Wei
Outcome results
None listed