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Pycnogenol for the Treatment of Lymphedema

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214032
First received: September 13, 2005
Last updated: January 7, 2008
Last verified: January 2008
History of Changes
  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 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:

U.S. FDA Resources

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

  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

No publications provided

Responsible Party: Paul Hutson, Pharm.D, University of Wisconsin Comprehensive Cancer Center
ClinicalTrials.gov 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: January 7, 2008
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:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Pycnogenols
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013