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
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms
• Female Breast Cancer
• Lymphedema
• Lymphedema Arm
• Lymphedema of Upper Arm

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

External Links

•   Memorial Sloan Kettering Cancer Center