Horse Chestnut Seed Extract for Lymphedema

Study Overview
=================
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.

Official Title
-----------------
A Single-blind, Randomized Trial of Horse Chestnut Seed Extract for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors

Conditions
-----------------
Lymphedema of Arm

Intervention / Treatment
-----------------
* Drug: Horse Chestnut Seed Extract


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Horse Chestnut Seed Extract<br>Horse chestnut seed extract (escins, aesins) | Drug: Horse Chestnut Seed Extract<br>* Control (no intervention) vs Horse Chestnut Seed Extract<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of arm lymphedema |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - comparison of bioelectric impedance to measure lymphedema changes |  |  | 
| - validation of bioelectric impedance to measure lymphedema changes |  |  | 
| - validation of lymphedema questionnaire |  |  |