Horse Chestnut Seed Extract for Lymphedema

• ClinicalTrials.gov Identifier: NCT00213928
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: June 2, 2015
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Lymphedema of Arm	Drug: Horse Chestnut Seed Extract	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• 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 Start Date: May 2002
• Actual Primary Completion Date: September 2004
• Actual Study Completion Date: September 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Reduction of arm lymphedema

Secondary Outcome Measures :

1. - comparison of bioelectric impedance to measure lymphedema changes
2. - validation of bioelectric impedance to measure lymphedema changes
3. - validation of lymphedema questionnaire

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

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

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00213928 History of Changes
• Other Study ID Numbers: 2004-050; CC 01106 ( Other Identifier: IRB# 2002-050 )
• First Posted: September 21, 2005
• Last Update Posted: June 2, 2015
• Last Verified: July 2011

Additional relevant MeSH terms:

Lymphedema; Lymphatic Diseases