Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors

Completed · Phase 2

Conditions studied: Lymphedema, Breast, Cancer

In brief

The goal of this study is to evaluate the effectiveness of a standardized botanical extract of Pycnogenol as a treatment for stable arm lymphedema in breast cancer survivors.

Key facts

Study ID

NCT00064857

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

26

Starts

2003-08-01

Expected to finish

2007-08-01

Last updated by the study team

2008-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral (ipsilateral to breast cancer resection side) lymphedema of the upper extremity.
• Extravascular water ration of > 1.07/1 between affected vs. normal arm using multiple frequency bioelectric impedence
• Patient is > 2months from last surgical or radiation treatment to the affected axilla
• Renal and hepatic function:
• Creatinine clearance > 50ml/min, total bili <2 mg/dl, transaminases <1.5 x ULN
• Patient not pregnant or breastfeeding. Use of barrier contraception if sexually active.
• ECOG performance of 0-2
• Patient not allergic to pycnogenol

You may not qualify if…

• Patients treated with their first course of chemotherapy or radiation
• Chemotherapy or radiation to axillary lymph node will exclude patients for 8 weeks following treatment
• Patients with more than one episode of arm cellulitis, venous clot, or woody fibrosis of the affected arm. Antibiotics used to treat cellulitis must be completed at least 4 weeks prior to initial screening
• Patients with a defibrillator Midazolam study only: Patients requiring or benefiting from supplemental oxygen, patients allergic to cherries

Where it is running

• University of Wisconsin Comprehensive Cancer Center and School of Pharmacy — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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