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

Primary Purpose

Breast Cancer, Lymphedema

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Wuling San
placebo
Sponsored by
Fourth Affiliated Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Liuzhou Hospital of Traditional Chinese MedicineRecruiting
  • Liuzhou Maternity and Child Healthcare HospitalRecruiting
  • The Fourth Affiliated Hospital of Guangxi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wuling San

placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

volume changes % measured by perometry
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.

Secondary Outcome Measures

adverse events
number of participants with serious and non-serious adverse events

Full Information

First Posted
March 29, 2016
Last Updated
May 6, 2016
Sponsor
Fourth Affiliated Hospital of Guangxi Medical University
Collaborators
Liuzhou Maternity and Child Healthcare Hospital, Liuzhou Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02726477
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fourth Affiliated Hospital of Guangxi Medical University
Collaborators
Liuzhou Maternity and Child Healthcare Hospital, Liuzhou Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wuling San
Arm Type
Experimental
Arm 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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Wuling San
Intervention Description
Patients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Patients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation.
Primary Outcome Measure Information:
Title
volume changes % measured by perometry
Description
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.
Time Frame
baseline and 2 months
Secondary Outcome Measure Information:
Title
adverse events
Description
number of participants with serious and non-serious adverse events
Time Frame
baseline and 2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Peng
Phone
+86 07723815334
Email
labstar@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangcheng Wei
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangcheng Wei
Organizational Affiliation
Guangxi Medical University Institutional Review Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liuzhou Hospital of Traditional Chinese Medicine
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifan Sun
Email
syifan@126.com
Facility Name
Liuzhou Maternity and Child Healthcare Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolan Lv
Email
1588868@gmail.com
Facility Name
The Fourth Affiliated Hospital of Guangxi Medical University
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Peng
Phone
+86 18589966550
Email
labstar@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
10987238
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.
Results Reference
background
PubMed Identifier
27986736
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.
Results Reference
derived

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

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