Horse Chestnut Seed Extract for Lymphedema - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00213928

Purpose

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.

Condition	Intervention	Phase
- Arm Lymphedema	Drug: horse chestnut seed extract	Phase II

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer Cancer Lymphedema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Factorial Assignment
Official Title:	A Single-Blind, Randomized Trial of Horse Chestnut Seed Extract for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors

Further study details as provided by University of Wisconsin, Madison:

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

Estimated Enrollment:	48
Study Start Date:	May 2002
Study Completion Date:	December 2005
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	17 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213928

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:	UW School of Pharmacy ( Paul Hutson )
Study ID Numbers:	2004-050, CC 01106
Study First Received:	September 13, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00213928
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lymphedema
Lymphatic Diseases
Breast Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009