Status:
COMPLETED
Horse Chestnut Seed Extract for Lymphedema
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Lymphedema of Arm
Eligibility:
FEMALE
17+ years
Phase:
PHASE2
Brief Summary
To help Treat Lymphedema of the Arm in Breast Cancer Survivors with Horse chestnut Seed Extract
Detailed Description
The objectives of this study are to evaluate the effectiveness of escin (as horse chestnut seed extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and...
Eligibility Criteria
Inclusion
- Patient demonstrates unilateral (ipsilateral to breast cancer resection side) lymphedema of the upper extremity. An extravascular water ratio of ³1.1/1 between the affected vs normal arm using multiple-frequency bioelectric impedance will be used as a criterion for lymphedema. There is not upper limit to the extent of arm volume (lymphedema)
- Patient is greater than 6 months from last surgical and/or radiation treatment to the affected axilla.
Exclusion
- Patients may not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this lymphedema study (Last chemotherapy \> 4 weeks prior). Women who are being treated adjuvantly with tamoxifen, raloxifene, or an aromatase inhibitor remain eligible
- Patients with a history of recurrent (more than 1 episode) arm cellulitis, prior or existing venous clot, or considered to have "woody" fibrosis of the affected arm are not eligible. Antibiotics used to treat any prior episode of cellulitis must have be completed no more recently than 3 months prior to initial screening.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00213928
Start Date
May 1 2002
End Date
September 1 2008
Last Update
June 2 2015
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792