NCT00214032

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2002

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

October 5, 2015

Status Verified

January 1, 2008

Enrollment Period

4.5 years

First QC Date

September 13, 2005

Last Update Submit

October 1, 2015

Conditions

Lymphedema

Keywords

lymphedema of the arm in breast cancer survivors

Outcome Measures

Primary Outcomes (1)

  • reduction of arm lymphedema

    monthly

Secondary Outcomes (1)

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

    monthly

Study Arms (2)

1

EXPERIMENTAL

pycnogenol daily

Drug: Pycnogenol

2

PLACEBO COMPARATOR

placebo daily

Drug: Placebo

Interventions

PycnogenolDRUG

pycnogenol 300 mg daily

1
PlaceboDRUG

placebo 3 capsules daily

2

Eligibility Criteria

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

You may qualify if:

  • \> 6 months from last surgical and/or radiation treatment to the affected axilla
  • Unilateral lymphedema of the upper extremity

You may not qualify if:

  • May not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Lymphedema

Interventions

pycnogenols

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Paul R Hutson, PharmD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2002

Primary Completion

November 1, 2006

Study Completion

January 1, 2007

Last Updated

October 5, 2015

Record last verified: 2008-01

Locations

US(1)