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

• Status: Unknown status
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fourth Affiliated Hospital of Guangxi Medical University
• Collaborators: Liuzhou Hospital of Traditional Chinese Medicine; Liuzhou Maternity and Child Healthcare Hospital

Criteria

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.