Breast CancerNCT02726477
Efficacy and Safety of Wuling San on Breast Cancer-related Lymphedema
A study testing Wuling San in people with Breast Cancer and Lymphedema, run by Fourth Affiliated Hospital of Guangxi Medical University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- Wuling San
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 3 sitesChina
- Study dates
- Apr 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Xiangcheng Wei contact
China3 sites, 3 recruiting
- Recruiting
Liuzhou Hospital of Traditional Chinese Medicine
Liuzhou, Guangxi, 545000
Yifan Sun, syifan@126.com
- Recruiting
Liuzhou Maternity and Child Healthcare Hospital
Liuzhou, Guangxi, 545000
Xiaolan Lv, 1588868@gmail.com
- Recruiting
The Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi, 545000
Zheng Peng, +86 18589966550, labstar@qq.com
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- Wuling San, placebo
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wuling SanDrug
Patients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation.
placeboDrug
Patients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 2 months
Secondary outcomes (1)
adverse events
number of participants with serious and non-serious adverse events
Measured: baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fourth Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Liuzhou Maternity and Child Healthcare Hospital, Liuzhou Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Xiangcheng Wei, Principal investigator, Guangxi Medical University Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726477
- Sponsor's protocol ID
- PJK2016088
- Status last verified
- May 2016
- First submitted
- 29 Mar 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 10987238Zhu 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.
PubMed 27986736
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Wuling San on Breast Cancer-related Lymphedema
- ClinicalTrials.gov ID
- NCT02726477
- Acronym / sponsor ID
- PJK2016088
- Conditions
- Breast Cancer, Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fourth Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- Liuzhou Maternity and Child Healthcare Hospital, Liuzhou Hospital of Traditional Chinese Medicine
- Study start
- Apr 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wuling San | Experimental | Drug: Wuling SanThis 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. |
| placebo | Placebo comparator | Drug: placeboA 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wuling SanPatients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation. | Drug | Wuling San |
| placeboPatients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation. | Drug | placebo |
Primary outcome
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.
1 secondary outcome
adverse events
Time frame: baseline and 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Background: PubMed 10987238Andersen 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.
- Derived from this study: PubMed 27986736Zhu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangcheng Wei contact
Xiangcheng Wei principal investigator
Guangxi Medical University Institutional Review Board
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wuling San in people with Breast Cancer and Lymphedema, run by Fourth Affiliated Hospital of Guangxi Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Peng (+86 07723815334, labstar@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume changes % measured by perometry (time frame: baseline and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02726477, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.