Horse Chestnut Seed Extract for Lymphedema

Lymphedema of Arm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213928
• Other study ID #: 2004-050
• Secondary ID: CC 01106
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 29, 2015
• Start date: May 2002
• Est. completion date: September 2008

Study information

• Verified date: July 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2008
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Arm

Intervention

Drug:
• Horse Chestnut Seed Extract
Control (no intervention) vs Horse Chestnut Seed Extract

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of arm lymphedema
Secondary	- comparison of bioelectric impedance to measure lymphedema changes
Secondary	- validation of bioelectric impedance to measure lymphedema changes
Secondary	- validation of lymphedema questionnaire