Pycnogenol for the Treatment of Lymphedema

University of Wisconsin, Madison2 enrolled

Overview

The objectives of this study are to evaluate the effectiveness of Pycnogenol (French maritime pine bark extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and sensitivity of bioelectric impedence as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lymphedema

Interventions

PycnogenolDRUG

pycnogenol 300 mg daily

PlaceboDRUG

placebo 3 capsules daily

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \> 6 months from last surgical and/or radiation treatment to the affected axilla * Unilateral lymphedema of the upper extremity Exclusion Criteria: * May not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this study

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

reduction of arm lymphedema

Time frame: monthly

Secondary Outcomes

comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire

Time frame: monthly

Data from ClinicalTrials.gov

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