Pycnogenol for the Treatment of Lymphedema

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Lymphedema

Treatments: Drug: Pycnogenol; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00214032

CC 05302

NCCAM R21 A1724-01

2005-0047

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

2 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

pycnogenol daily

Treatment:

Drug: Pycnogenol

2

Placebo Comparator group

Description:

placebo daily

Treatment:

Drug: Placebo