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


Phase 2
18 Years
N/A
Not Enrolling
Female
Lymphedema

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

reduction of arm lymphedema

Outcome Time Frame:

monthly

Safety Issue:

No

Principal Investigator

Paul R Hutson, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

2005-0047

NCT ID:

NCT00214032

Start Date:

May 2002

Completion Date:

January 2007

Related Keywords:

  • Lymphedema
  • lymphedema of the arm in breast cancer survivors
  • Breast Neoplasms
  • Lymphedema

Name

Location
University of Wisconsin Madison,, Wisconsin  53792-5666