Pycnogenol for the Treatment of Lymphedema

Lymphedema Clinical Trial

Official title:

Treatment of Arm Lymphedema in Breast Cancer Survivors: A Double-Blind, Randomized Study of Pycnogenol vs. Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214032
• Other study ID #: 2005-0047
• Secondary ID: NCCAM R21 A1724-
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: October 1, 2015
• Start date: May 2002
• Est. completion date: January 2007

Study information

• Verified date: January 2008
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: January 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema

Intervention

Drug:
• Pycnogenol
pycnogenol 300 mg daily
• Placebo
placebo 3 capsules daily

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of arm lymphedema		monthly	No
Secondary	comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire		monthly	No