search
Back to results

Horse Chestnut Seed Extract for Lymphedema

Primary Purpose

Lymphedema of Arm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Horse Chestnut Seed Extract
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphedema of Arm

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Horse Chestnut Seed Extract

Arm Description

Horse chestnut seed extract (escins, aesins)

Outcomes

Primary Outcome Measures

Reduction of arm lymphedema

Secondary Outcome Measures

- comparison of bioelectric impedance to measure lymphedema changes
- validation of bioelectric impedance to measure lymphedema changes
- validation of lymphedema questionnaire

Full Information

First Posted
September 13, 2005
Last Updated
May 29, 2015
Sponsor
University of Wisconsin, Madison
search

1. Study Identification

Unique Protocol Identification Number
NCT00213928
Brief Title
Horse Chestnut Seed Extract for Lymphedema
Official Title
A Single-blind, Randomized Trial of Horse Chestnut Seed Extract for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Arm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Horse Chestnut Seed Extract
Arm Type
Active Comparator
Arm Description
Horse chestnut seed extract (escins, aesins)
Intervention Type
Drug
Intervention Name(s)
Horse Chestnut Seed Extract
Intervention Description
Control (no intervention) vs Horse Chestnut Seed Extract
Primary Outcome Measure Information:
Title
Reduction of arm lymphedema
Secondary Outcome Measure Information:
Title
- comparison of bioelectric impedance to measure lymphedema changes
Title
- validation of bioelectric impedance to measure lymphedema changes
Title
- validation of lymphedema questionnaire

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul R Hutson, PharmD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Horse Chestnut Seed Extract for Lymphedema

We'll reach out to this number within 24 hrs