NCT00213928

Brief Summary

To help Treat Lymphedema of the Arm in Breast Cancer Survivors with Horse chestnut Seed Extract

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 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
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
1 year 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
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

June 2, 2015

Status Verified

July 1, 2011

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

May 29, 2015

Conditions

Lymphedema of Arm

Outcome Measures

Primary Outcomes (1)

  • Reduction of arm lymphedema

Secondary Outcomes (3)

  • - comparison of bioelectric impedance to measure lymphedema changes

  • - validation of bioelectric impedance to measure lymphedema changes

  • - validation of lymphedema questionnaire

Study Arms (2)

Control

NO INTERVENTION

Horse Chestnut Seed Extract

ACTIVE COMPARATOR

Horse chestnut seed extract (escins, aesins)

Drug: Horse Chestnut Seed Extract

Interventions

Horse Chestnut Seed ExtractDRUG

Control (no intervention) vs Horse Chestnut Seed Extract

Horse Chestnut Seed Extract

Eligibility Criteria

Age17 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient demonstrates unilateral (ipsilateral to breast cancer resection side) lymphedema of the upper extremity. An extravascular water ratio of ³1.1/1 between the affected vs normal arm using multiple-frequency bioelectric impedance will be used as a criterion for lymphedema. There is not upper limit to the extent of arm volume (lymphedema)
  • Patient is greater than 6 months from last surgical and/or radiation treatment to the affected axilla.

You may not qualify if:

  • Patients may not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this lymphedema study (Last chemotherapy \> 4 weeks prior). Women who are being treated adjuvantly with tamoxifen, raloxifene, or an aromatase inhibitor remain eligible
  • Patients with a history of recurrent (more than 1 episode) arm cellulitis, prior or existing venous clot, or considered to have "woody" fibrosis of the affected arm are not eligible. Antibiotics used to treat any prior episode of cellulitis must have be completed no more recently than 3 months prior to initial screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

horse chestnut seed

Study Officials

  • Paul R Hutson, PharmD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
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

September 1, 2004

Study Completion

September 1, 2008

Last Updated

June 2, 2015

Record last verified: 2011-07

Locations

US(1)