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Horse Chestnut Seed Extract for Lymphedema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00213928
First received: September 13, 2005
Last updated: May 29, 2015
Last verified: July 2011
History of Changes
  Purpose
To help Treat Lymphedema of the Arm in Breast Cancer Survivors with Horse chestnut Seed Extract

Condition Intervention Phase
Lymphedema of Arm
 Drug: Horse Chestnut Seed Extract
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphedema
U.S. FDA Resources

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
Enrollment: 56
Study Start Date: May 2002
Study Completion Date: September 2008
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility
Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00213928     History of Changes
Other Study ID Numbers: 2004-050  CC 01106 
Study First Received: September 13, 2005
Last Updated: May 29, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on September 26, 2016