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

Arm | Intervention/treatment |
---|---|
No Intervention: Control | |
Active Comparator: Horse Chestnut Seed Extract
Horse chestnut seed extract (escins, aesins)
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Drug: Horse Chestnut Seed Extract
Control (no intervention) vs Horse Chestnut Seed Extract |
- Reduction of arm lymphedema
- - comparison of bioelectric impedance to measure lymphedema changes
- - validation of bioelectric impedance to measure lymphedema changes
- - validation of lymphedema questionnaire

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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 |
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.

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
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Paul R Hutson, PharmD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00213928 |
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 |
Lymphedema Lymphatic Diseases |