Cancer Clinical Trial
Official title:
Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | August 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Comprehensive Cancer Center and School of Pharmacy | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
National Center for Complementary and Integrative Health (NCCIH) |
United States,
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