NCT00064857

Brief Summary

The goal of this study is to evaluate the effectiveness of a standardized botanical extract of Pycnogenol as a treatment for stable arm lymphedema in breast cancer survivors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2003

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

Enrollment Period

4 years

First QC Date

July 14, 2003

Last Update Submit

April 21, 2008

Conditions

LymphedemaBreastCancer

Keywords

lymphedemabreastcancerplant preparationherbal preparationpine bark extract

Interventions

PycnogenolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral (ipsilateral to breast cancer resection side) lymphedema of the upper extremity.
  • Extravascular water ration of \> 1.07/1 between affected vs. normal arm using multiple frequency bioelectric impedence
  • Patient is \> 2months from last surgical or radiation treatment to the affected axilla
  • Renal and hepatic function:
  • Creatinine clearance \> 50ml/min, total bili \<2 mg/dl, transaminases \<1.5 x ULN
  • Patient not pregnant or breastfeeding. Use of barrier contraception if sexually active.
  • ECOG performance of 0-2
  • Patient not allergic to pycnogenol

You may not qualify if:

  • Patients treated with their first course of chemotherapy or radiation
  • Chemotherapy or radiation to axillary lymph node will exclude patients for 8 weeks following treatment
  • Patients with more than one episode of arm cellulitis, venous clot, or woody fibrosis of the affected arm. Antibiotics used to treat cellulitis must be completed at least 4 weeks prior to initial screening
  • Patients with a defibrillator Midazolam study only: Patients requiring or benefiting from supplemental oxygen, patients allergic to cherries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Comprehensive Cancer Center and School of Pharmacy

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

LymphedemaNeoplasms

Interventions

pycnogenols

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • James F. Cleary, M.B.B.S.

    University of Wisconsin, Madison

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 14, 2003

First Posted

July 16, 2003

Study Start

August 1, 2003

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations

US(1)