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Pycnogenol for the Treatment of Lymphedema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00214032
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lymphedema Drug: Pycnogenol Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Arm Lymphedema in Breast Cancer Survivors: A Double-Blind, Randomized Study of Pycnogenol vs. Placebo
Study Start Date : May 2002
Actual Primary Completion Date : November 2006
Actual Study Completion Date : January 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
pycnogenol daily
 Drug: Pycnogenol
pycnogenol 300 mg daily
Placebo Comparator: 2
placebo daily
 Drug: Placebo
placebo 3 capsules daily


Outcome Measures
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Primary Outcome Measures :
  1. reduction of arm lymphedema [ Time Frame: monthly ]

Secondary Outcome Measures :
  1. comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire [ Time Frame: monthly ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214032


Locations
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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)
Investigators
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Principal Investigator: Paul R Hutson, PharmD University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214032    
Other Study ID Numbers: 2005-0047
NCCAM R21 A1724-01
CC 05302
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: January 2008
Keywords provided by University of Wisconsin, Madison:
lymphedema of the arm in breast cancer survivors
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases
Pycnogenols
Adjuvants, Immunologic
Immunologic Factors
 Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Platelet Aggregation Inhibitors