A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 285
- Locations
- 14
- Primary Endpoint
- The difference between the baseline and postoperative arm volume measurement
Study Overview
Brief Summary
The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female sex
- •Diagnosis of breast cancer
- •Ages 18 to 75 years
- •Consented for unilateral ALND or for unilateral SLNB with possible ALND
Exclusion Criteria
- •Does not speak English
- •Does not fit into study garment
- •Axillary recurrence
- •History of ALND
- •Requirement of bilateral ALND for the treatment of breast cancer
- •Treatment with SLNB only
- •Known anaphylactic allergy to ICG dye used in ILR
- •Impaired decision-making capacity
Arms & Interventions
Participants with Breast Cancer
Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.
Intervention: Immediate Lymphatic Reconstruction (Procedure)
Participants with Breast Cancer
Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.
Intervention: Volumetric arm measurements (Diagnostic Test)
Participants with Breast Cancer
Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.
Intervention: Lymphatic massage (Other)
Participants with Breast Cancer
Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.
Intervention: Range of motion exercises (Other)
Participants with Breast Cancer
Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.
Intervention: Compression garment use (Other)
Outcomes
Primary Outcomes
The difference between the baseline and postoperative arm volume measurement
Time Frame: Up to 24 months
The primary objective is to determine the efficacy of a prevention program in decreasing the development of lymphedema in participants treated for breast cancer with Axillary Lymph Node Dissection/ALND by use of arm volume measurements. A ≥ 10% increase in RVC (arm volume difference between the affected and unaffected arms) between baseline and postoperative measures occurring at 12 months or later will indicate the development of lymphedema
Secondary Outcomes
No secondary outcomes reported