Clinical trial NCT02726477: Efficacy and Safety of Wuling San on Breast Cancer-related Lymphedema
Official title: Efficacy and Safety of Wuling San on Breast Cancer-related Lymphedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lymphedema
Lead sponsor: Fourth Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
Collaborators: name: Liuzhou Maternity and Child Healthcare Hospital
name: Liuzhou Hospital of Traditional Chinese Medicine
First posted: 2016-04-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: volume changes % measured by perometry
timeFrame: baseline and 2 months
Secondary outcomes:
measure: adverse events
timeFrame: baseline and 2 months
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: Liuzhou Hospital of Traditional Chinese Medicine
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou Maternity and Child Healthcare Hospital
state: Guangxi
city: Liuzhou
country: China
facility: The Fourth Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: Guangxi Medical University Institutional Review Board
name: Xiangcheng Wei
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen L, Hojris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39(3):399-405. doi: 10.1080/028418600750013186.
citation: Zhu H, Peng Z, Dai M, Zou Y, Qin F, Chen J, Song L, He B, Lv X, Dai S. Efficacy and safety of Wuling San for treatment of breast-cancer-related upper extremity lymphoedema: study protocol for a pilot trial. BMJ Open. 2016 Dec 16;6(12):e012515. doi: 10.1136/bmjopen-2016-012515.