Pycnogenol for the Treatment of Lymphedema

This study has been completed.
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: October 1, 2015
Last verified: January 2008

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.

Condition Intervention Phase
Drug: Pycnogenol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Arm Lymphedema in Breast Cancer Survivors: A Double-Blind, Randomized Study of Pycnogenol vs. Placebo

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • reduction of arm lymphedema [ Time Frame: monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire [ Time Frame: monthly ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: May 2002
Study Completion Date: January 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
pycnogenol daily
Drug: Pycnogenol
pycnogenol 300 mg daily
Placebo Comparator: 2
placebo daily
Drug: Placebo
placebo 3 capsules daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00214032

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Paul R Hutson, PharmD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison Identifier: NCT00214032     History of Changes
Other Study ID Numbers: 2005-0047, NCCAM R21 A1724-01, CC 05302
Study First Received: September 13, 2005
Last Updated: October 1, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
lymphedema of the arm in breast cancer survivors

Additional relevant MeSH terms:
Lymphatic Diseases
Adjuvants, Immunologic
Hematologic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses processed this record on October 08, 2015