Clinical trial · Interventional
Efficacy and Safety of Wuling San on Breast Cancer-related Lymphedema
NCT02726477CI-TRIAL-00022048unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| Wuling San | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Wuling San
- 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.
- interventionNames
- Drug: Wuling San
- type
- PLACEBO_COMPARATOR
- label
- placebo
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDAndersen 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 10987238
- DERIVEDZhu 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 27986736