Pycnogenol for the Treatment of Lymphedema

Phase 2

Completed

• Conditions: Lymphedema
• Interventions: Drug: Placebo; Drug: Pycnogenol

• Registration Number: NCT00214032
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-11
• Study Completion: 2007-01
• Status Verified: 2008-01
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Placebo	placebo daily
1	Pycnogenol	pycnogenol daily

Primary Outcome Measures

Name	Time	Method
reduction of arm lymphedema	monthly

Secondary Outcome Measures

Name	Time	Method
comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire	monthly

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States