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Horse Chestnut Seed Extract for Lymphedema
This study has been completed.
Sponsor:
University of Wisconsin, Madison
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
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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 (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 |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphedema
Drug Information available for:
Horse chestnut
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) |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00213928
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 ( Other Identifier: IRB# 2002-050 ) |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 29, 2015 |
Additional relevant MeSH terms:
|
Lymphedema Lymphatic Diseases |
ClinicalTrials.gov processed this record on September 21, 2017