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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Actual Primary Completion Date : | November 2006 |
Actual Study Completion Date : | January 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
pycnogenol daily
|
Drug: Pycnogenol
pycnogenol 300 mg daily |
Placebo Comparator: 2
placebo daily
|
Drug: Placebo
placebo 3 capsules daily |
- reduction of arm lymphedema [ Time Frame: monthly ]
- comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire [ Time Frame: monthly ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Paul R Hutson, PharmD | University of Wisconsin, Madison |
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 |
lymphedema of the arm in breast cancer survivors |
Lymphedema Lymphatic Diseases Pycnogenols Adjuvants, Immunologic Immunologic Factors |
Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Platelet Aggregation Inhibitors |