Pycnogenol for the Treatment of Lymphedema

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00214032

Enrollment

Registered

2005-09-21

Start date

2002-05-31

Completion date

2007-01-31

Last updated

2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Keywords

lymphedema of the arm in breast cancer survivors

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.

Interventions

DRUGPycnogenol

pycnogenol 300 mg daily

DRUGPlacebo

placebo 3 capsules daily

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
reduction of arm lymphedema	monthly

Secondary

Measure	Time frame
comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire	monthly

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026