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Completed

NCT Number: NCT00214032

Pycnogenol for the Treatment of Lymphedema

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.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pycnogenol

Drug

pycnogenol 300 mg daily

Placebo

Drug

placebo 3 capsules daily

Primary outcomes

  1. reduction of arm lymphedema

    Time frame: monthly

Secondary outcomes

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

    Time frame: monthly

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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