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Pycnogenol for the Treatment of Lymphedema

Primary Purpose

Lymphedema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pycnogenol
Placebo
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring lymphedema of the arm in breast cancer survivors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

pycnogenol daily

placebo daily

Outcomes

Primary Outcome Measures

reduction of arm lymphedema

Secondary Outcome Measures

comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire

Full Information

First Posted
September 13, 2005
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00214032
Brief Title
Pycnogenol for the Treatment of Lymphedema
Official Title
Treatment of Arm Lymphedema in Breast Cancer Survivors: A Double-Blind, Randomized Study of Pycnogenol vs. Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
lymphedema of the arm in breast cancer survivors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
pycnogenol daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo daily
Intervention Type
Drug
Intervention Name(s)
Pycnogenol
Intervention Description
pycnogenol 300 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo 3 capsules daily
Primary Outcome Measure Information:
Title
reduction of arm lymphedema
Time Frame
monthly
Secondary Outcome Measure Information:
Title
comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire
Time Frame
monthly

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul R Hutson, PharmD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Pycnogenol for the Treatment of Lymphedema

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