Pycnogenol for the Treatment of Lymphedema

NCT ID: NCT00214032

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphedema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

pycnogenol daily

Group Type EXPERIMENTAL

Pycnogenol

Intervention Type DRUG

pycnogenol 300 mg daily

2

placebo daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo 3 capsules daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pycnogenol

pycnogenol 300 mg daily

Intervention Type DRUG

Placebo

placebo 3 capsules daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul R Hutson, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCCAM R21 A1724-01

Identifier Type: -

Identifier Source: secondary_id

CC 05302

Identifier Type: -

Identifier Source: secondary_id

2005-0047

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Topical Tacrolimus for Breast Cancer-related Lymphedema
NCT06306274 ENROLLING_BY_INVITATION PHASE2/PHASE3
Use of Stem Cells in Lymphedema Post Mastectomy
NCT01112189 COMPLETED PHASE1/PHASE2