Overview

Horse Chestnut Seed Extract for Lymphedema

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
Female
Summary
To help Treat Lymphedema of the Arm in Breast Cancer Survivors with Horse chestnut Seed Extract
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Wisconsin, Madison
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.