Pycnogenol for the Treatment of Lymphedema - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00214032

Purpose

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
Lymphedema	Drug: Pycnogenol Drug: Placebo	Phase II

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer Cancer Lymphedema

Drug Information available for: Pycnogenol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment of Arm Lymphedema in Breast Cancer Survivors: A Double-Blind, Randomized Study of Pycnogenol vs. Placebo

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
1: Experimental pycnogenol daily	Drug: Pycnogenol pycnogenol 300 mg daily
2: Placebo Comparator placebo daily	Drug: Placebo placebo 3 capsules daily

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214032

Locations

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Paul R Hutson, PharmD

University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconsin Comprehensive Cancer Center ( Paul Hutson, Pharm.D )
Study ID Numbers:	2005-0047, NCCAM R21 A1724-01, CC 05302
Study First Received:	September 13, 2005
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00214032
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

lymphedema of the arm in breast cancer survivors

Study placed in the following topic categories:

Lymphedema
Lymphatic Diseases
Pycnogenols
Breast Neoplasms

Additional relevant MeSH terms:

Immunologic Factors
Therapeutic Uses
Hematologic Agents
Physiological Effects of Drugs

Adjuvants, Immunologic
Platelet Aggregation Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009