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


Phase 2
17 Years
N/A
Not Enrolling
Female
Lymphedema of Arm

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Reduction of arm lymphedema

Principal Investigator

Paul R Hutson, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

2004-050

NCT ID:

NCT00213928

Start Date:

May 2002

Completion Date:

September 2008

Related Keywords:

  • Lymphedema of Arm
  • Lymphedema

Name

Location

University of WisconsinMadison,, Wisconsin  53792-5666