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NCT Number: NCT06144164

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

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.

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Key information

Conditions

Lymphedema Breast Cancer Breast Carcinoma Breast Diseases Breast Neoplasms Female Breast Cancer Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Arm Lymphedema of Upper Arm Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate Lymphatic Reconstruction

Procedure

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

Other names: ILR

Volumetric arm measurements

Diagnostic Test

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

Lymphatic massage

Other

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

Other

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

Other

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

Primary outcomes

  1. The difference between the baseline and postoperative arm volume measurement

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Babak Mahrara, MD

CONTACT

[email protected]

646-608-8085

Michelle Coriddi, MD

CONTACT

[email protected]

646-608-8042

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Nov 22, 2023
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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