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

Phase 3

Recruiting

• Conditions: Lymphedema; Lymphedema of Upper Arm; Breast Carcinoma; Lymphedema Arm; Breast Cancer; Female Breast Cancer

• Registration Number: NCT06144164
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-16
• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2030-03-16
• Study Completion: 2030-03-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 285

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The difference between the baseline and postoperative arm volume measurement	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

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, 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 Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, 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, United States