Pycnogenol for the Treatment of Lymphedema | NCT00214032

Studies
Pycnogenol for the Treatment of Lymphedema

NCT00214032

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Oct 5, 2015Estimated

Enrollment

2Actual

Phase

Phase 2

Conditions

Lymphedema

Interventions

Pycnogenol
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Nov 2006Actual

Completion Date

Jan 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2015

Last Update Posted Date

Oct 5, 2015Estimated

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	pycnogenol daily	Drug: Pycnogenol
2	Placebo Comparator	placebo daily	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pycnogenol	Drug	pycnogenol 300 mg daily	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction of arm lymphedema		monthly

Secondary Outcomes

Measure	Description	Time Frame
comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire		monthly

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul R Hutson, PharmD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin		Madison	Wisconsin	53792	United States

Condition Browse Module

MeSH Terms

ID	Term
D008209	Lymphedema

Ancestor Terms

ID	Term
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C024070	pycnogenols

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
NCCAM R21 A1724-01
CC 05302