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Completed

NCT Number: NCT00213928

Horse Chestnut Seed Extract for Lymphedema

To help Treat Lymphedema of the Arm in Breast Cancer Survivors with Horse chestnut Seed Extract

Completed

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Key information

Conditions

Age range

17 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Horse Chestnut Seed Extract

Drug

Control (no intervention) vs Horse Chestnut Seed Extract

Primary outcomes

  1. Reduction of arm lymphedema

Secondary outcomes

  1. - comparison of bioelectric impedance to measure lymphedema changes

  2. - validation of bioelectric impedance to measure lymphedema changes

  3. - validation of lymphedema questionnaire

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

A Single-blind, Randomized Trial of Horse Chestnut Seed Extract for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors

Important dates

Study start
2002
Primary completion
2004
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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