Lymphedema of Arm
Conditions
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 sensitivity of bioelectric impedance as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.
Interventions
DRUGHorse Chestnut Seed Extract
Control (no intervention) vs Horse Chestnut Seed Extract
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
17 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of arm lymphedema | — |
Secondary
| Measure | Time frame |
|---|---|
| - comparison of bioelectric impedance to measure lymphedema changes | — |
| - validation of bioelectric impedance to measure lymphedema changes | — |
| - validation of lymphedema questionnaire | — |
Countries
United States
Outcome results
None listed