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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02726477
• Other study ID #: PJK2016088
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2016
• Last updated: May 6, 2016
• Start date: April 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2016
• Source: Fourth Affiliated Hospital of Guangxi Medical University
• Contact: Zheng Peng
• Phone: +86 07723815334
• Email: labstar[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

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

Locations

Country	Name	City	State
China	Liuzhou Hospital of Traditional Chinese Medicine	Liuzhou	Guangxi
China	Liuzhou Maternity and Child Healthcare Hospital	Liuzhou	Guangxi
China	The Fourth Affiliated Hospital of Guangxi Medical University	Liuzhou	Guangxi

Sponsors (3)

Lead Sponsor	Collaborator
Fourth Affiliated Hospital of Guangxi Medical University	Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou Maternity and Child Healthcare Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Andersen L, Højris 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	adverse events	number of participants with serious and non-serious adverse events	baseline and 2 months	No