Horse Chestnut Seed Extract for Lymphedema

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

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

Study Overview

• Status: Completed
• Conditions: Lymphedema of Arm
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: Horse Chestnut Seed Extract; Horse chestnut seed extract (escins, aesins)	Drug: Horse Chestnut Seed Extract; Control (no intervention) vs Horse Chestnut Seed Extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of arm lymphedema

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Paul R Hutson, PharmD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 29, 2015
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 2004-050; CC 01106 (Other Identifier: IRB# 2002-050)