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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Pycnogenols

Criteria

Inclusion criteria:

• 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

Exclusion criteria:

• 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