A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Breast Cancer, Breast Carcinoma, Female Breast Cancer

Intervention / Treatment
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* Procedure: Immediate Lymphatic Reconstruction
* Diagnostic Test: Volumetric arm measurements
* Other: Lymphatic massage
* Other: Range of motion exercises
* Other: Compression garment use


Participation Criteria
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Eligibility Criteria
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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: Male sex Does not speak English 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Breast Cancer<br>Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection. | Procedure: Immediate Lymphatic Reconstruction<br>* Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection<br>* Other names: ILR;Diagnostic Test: Volumetric arm measurements<br>* Volumetric arm measurements will occur at each in-person postoperative visit time points.<br>Other: Lymphatic massage<br>* Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed<br>Other: Range of motion exercises<br>* Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed<br>Other: Compression garment use<br>* Participants will use compression garments 24 to 48 h after surgery and will continue daily use for at least 8 h a day for 3 months or until 3 months after any adjuvant treatments are completed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between the baseline and postoperative arm volume measurement | 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 | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immediate lymphatic reconstruction, axillary lymph node dissection, Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Breast cancer, breast carcinoma, female breast cancer, Memorial Sloan Kettering Cancer Center, 23-303