The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2010 |
| End Date: | December 2012 |
| Contact: | Marita Truax, RN, BSN |
| Email: | TruaxM@mlhs.org |
| Phone: | 484-337-8712 |
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
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
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.
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.
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.
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