NCT01521000

Brief Summary

Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema. Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema. Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema. The successful completion of this study will address whether bioimpedance analysis is a reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we intend to evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema. And most importantly, we will evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the research and findings of this study, which may have future bearing on the post-operative therapeutic management of subjects with pre-clinical lymphedema following axillary surgery. Study Design:Randomized, Pilot Study

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 30, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

February 9, 2011

Last Update Submit

January 25, 2012

Conditions

Breast Cancer

Keywords

Breast CancerLymphedemaSentinel Node BiopsyAxillary Dissection

Outcome Measures

Primary Outcomes (1)

  • To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema.

    Evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease.

    2 years

Secondary Outcomes (1)

  • 200 women will have bioimpedance and volume displacement measurements to evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema as compared to standard (volume displacement)

    2 years

Study Arms (2)

Observation

NO INTERVENTION

Observation arm will continue to be followed with serial L-Dex and water volume displacement methods.

Device: Garment Sleeve

Intervention-garment sleeve

OTHER

If the L-Dex is outside the normal range, or has increased 10 units from baseline, the patient will then be randomized to wear a compression sleeve (20 to 30 mm of Hg) daily for 4 weeks or observation (no sleeve). After 4 weeks, L-Dex measurements and water volume displacement will be reassessed in the treatment group.

Device: Garment Sleeve

Interventions

Garment SleeveDEVICE

compression sleeve (20 to 30 mm of Hg)

Intervention-garment sleeveObservation

Eligibility Criteria

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

You may qualify if:

  • are female
  • have operable, early stage breast cancer stage 0 - IIIA
  • undergo axillary evaluation with either sentinel lymph node biopsy or axillary lymph node dissection
  • are aged \> 18 years of age at the date of enrollment
  • are willing to sign an informed consent form

You may not qualify if:

  • are male
  • have had a bilateral axillary surgery
  • do not undergo axillary evaluation
  • are a minor
  • cannot consider the issues involved in making an informed and autonomous decision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Breast Center at Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Andrea V Barrio, MD

    Bryn Mawr Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marita Truax, RN, BSN

CONTACT

484-337-8712TruaxM@mlhs.org

Eileen A Morgans, RN,BSN,CBCN

CONTACT

484-337-8744morgansE@mhls.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2011

First Posted

January 30, 2012

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

January 30, 2012

Record last verified: 2012-01

Locations

US(1)