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Horse Chestnut Seed Extract for Lymphedema

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

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arms and Interventions
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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
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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
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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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: July 2011

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases