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NCT06144164 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06144164
Other study ID # 23-303
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 16, 2023
Est. completion date March 16, 2030

Study information
Verified date June 2024
Source Memorial Sloan Kettering Cancer Center
Contact Michelle Coriddi, MD
Phone 646-608-8042
Email coriddim@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 285
Est. completion date March 16, 2030
Est. primary completion date March 16, 2030
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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 - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Immediate Lymphatic Reconstruction
Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection
Diagnostic Test:
• Volumetric arm measurements
Volumetric arm measurements will occur at each in-person postoperative visit time points.
Other:
• Lymphatic massage
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
• Range of motion exercises
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
• Compression garment use
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

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack (Limited Protocol Activities) Commack New York
United States Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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