L-Dex: The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient

Sponsor

Main Line Health (Other)

Overall Status

Unknown status

CT.gov ID

NCT01521000

Collaborator

Sharpe-Strumia Research Foundation (Other)

200

Enrollment

Location

Arms

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Garment Sleeve	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient

Study Start Date :

Jul 1, 2010

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Observation Observation arm will continue to be followed with serial L-Dex and water volume displacement methods.	Device: Garment Sleeve compression sleeve (20 to 30 mm of Hg)
Other: Intervention-garment sleeve 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 compression sleeve (20 to 30 mm of Hg)

Arm

Intervention/Treatment

No Intervention: Observation

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

Device: Garment Sleeve

compression sleeve (20 to 30 mm of Hg)

Other: Intervention-garment sleeve

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

compression sleeve (20 to 30 mm of Hg)

Outcome Measures

Primary Outcome Measures

To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema. [2 years]
Evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease.

Secondary Outcome Measures

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]
Evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.