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

Fourth Affiliated Hospital of Guangxi Medical University

Status: Unknown

Conditions: Breast Cancer; Lymphedema

Treatments: Drug: placebo; Drug: Wuling San

Study type: Interventional

Funder types: Other

Identifiers

NCT02726477

PJK2016088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Wuling San

Experimental group

Description:

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.

Treatment:

Drug: Wuling San

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo