Horse Chestnut Seed Extract for Lymphedema

University of Wisconsin (UW)

Status and phase

Completed

Phase 2

Conditions

Lymphedema of Arm

Treatments

Drug: Horse Chestnut Seed Extract

Study type

Interventional

Funder types

Other

Identifiers

NCT00213928

CC 01106 (Other Identifier)

2004-050

Details and patient eligibility

About

To help Treat Lymphedema of the Arm in Breast Cancer Survivors with Horse chestnut Seed Extract

Full 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 sensitivity of bioelectric impedance as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.

Enrollment

56 patients

Sex

Female

Ages

17+ years old

Volunteers

No Healthy Volunteers

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.