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Pycnogenol for the Treatment of Lymphedema

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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

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 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
Primary Completion Date : November 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

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
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
Principal Investigator: Paul R Hutson, PharmD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214032     History of Changes
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:
Lymphedema
Lymphatic Diseases
Pycnogenols
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors