NCT02726477

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Fourth Affiliated Hospital of Guangxi Medical University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Lymphedema

Interventions

Type	Name	Description
DRUG	Wuling San	Patients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation.
DRUG	placebo	Patients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-09-01
• Completion: 2018-05-01
• First posted: 2016-04-01
• Last updated: 2016-05-09

Locations

3 sites across 1 country: China