Horse Chestnut Seed Extract for Lymphedema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2008-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lymphedema of Arm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Horse Chestnut Seed Extract

Horse chestnut seed extract (escins, aesins)

Group Type ACTIVE_COMPARATOR

Horse Chestnut Seed Extract

Intervention Type DRUG

Control (no intervention) vs Horse Chestnut Seed Extract

Interventions

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Horse Chestnut Seed Extract

Control (no intervention) vs Horse Chestnut Seed Extract

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No