RecruitingPhase 3NCT06144164

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

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

285 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a comprehensive prevention program — including compression garments, exercise, and special imaging — to reduce the risk of lymphedema (painful arm swelling) in women with breast cancer who need lymph node removal from the armpit. **You may be eligible if...** - You are a female between 18 and 75 years old - You have been diagnosed with breast cancer - You are scheduled for lymph node removal from one armpit, or a sentinel node biopsy that may lead to full lymph node removal **You may NOT be eligible if...** - You are male - You do not speak English - You do not fit into the study compression garment - You have a history of previous armpit lymph node removal - Your cancer has returned to the armpit - You need lymph node removal from both armpits - You are allergic to the dye used in the lymphatic imaging procedure - You have difficulty making decisions for yourself Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREImmediate Lymphatic Reconstruction

Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection

DIAGNOSTIC_TESTVolumetric arm measurements

Volumetric arm measurements will occur at each in-person postoperative visit time points.

OTHERLymphatic 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

OTHERRange of motion exercises

OTHERCompression 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