NCT02726477

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

March 29, 2016

Last Update Submit

May 6, 2016

Conditions

Breast CancerLymphedema

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and 2 months

Secondary Outcomes (1)

  • adverse events

    baseline and 2 months

Study Arms (2)

Wuling San

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Wuling SanDRUG

Patients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation.

Wuling San
placeboDRUG

Patients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation.

placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Liuzhou Hospital of Traditional Chinese Medicine

Liuchow, Guangxi, 545000, China

RECRUITING

Liuzhou Maternity and Child Healthcare Hospital

Liuchow, Guangxi, 545000, China

RECRUITING

The Fourth Affiliated Hospital of Guangxi Medical University

Liuchow, Guangxi, 545000, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 10987238BACKGROUND

  • 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.

    PMID: 27986736DERIVED

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Xiangcheng Wei

    Guangxi Medical University Institutional Review Board

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Peng

CONTACT

+86 07723815334labstar@qq.com

Xiangcheng Wei

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 1, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2017

Study Completion

May 1, 2018

Last Updated

May 9, 2016

Record last verified: 2016-05

Locations

CN(3)