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

May 6, 2016 updated by: Fourth Affiliated Hospital of Guangxi Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Liuzhou, Guangxi, China, 545000
        • Recruiting
        • The Fourth Affiliated Hospital of Guangxi Medical University
        • Contact:
      • Liuzhou, Guangxi, China, 545000
        • Recruiting
        • Liuzhou Maternity and child Healthcare Hospital
        • Contact:
      • Liuzhou, Guangxi, China, 545000
        • Recruiting
        • Liuzhou Hospital of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wuling San

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.
Drug: Wuling San
Patients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation.
Placebo Comparator: placebo
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.
Drug: placebo
Patients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume changes % measured by perometry
Time Frame: 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.
baseline and 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: baseline and 2 months
number of participants with serious and non-serious adverse events
baseline and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fourth Affiliated Hospital of Guangxi Medical University

Collaborators

Liuzhou Maternity and Child Healthcare Hospital
Liuzhou Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Xiangcheng Wei, Guangxi Medical University Institutional Review Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Estimate)

May 9, 2016

Last Update Submitted That Met QC Criteria

May 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJK2016088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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