Recruiting
Phase 3

Lymphedema Prevention

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06144164

Conditions

Lymphedema

Lymphedema Arm

Lymphedema of Upper Arm

Breast Cancer

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Immediate Lymphatic Reconstruction

Volumetric arm measurements

Lymphatic massage

Range of motion exercises

Compression garment use

Study Details

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.

Conditions

Lymphedema

Lymphedema Arm

Lymphedema of Upper Arm

Breast Cancer

Breast Carcinoma

Study ID

NCT06144164

Start date

Nov 16, 2023

Status verified date

Nov, 2025

Completion date

Mar 16, 2030

Anticipated

Primary completion date

Mar 16, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

285 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Participants with Breast Cancer

Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.

Interventions

Immediate Lymphatic Reconstruction

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

Volumetric arm measurements

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

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

Primary outcome measure

  • The difference between the baseline and postoperative arm volume measurement [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Michelle Coriddi, MD

646-608-8042coriddim@mskcc.org

Babak Mahrara, MD

646-608-8085mehrarab@MSKCC.ORG

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Michelle Coriddi, MD

646-608-8042

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Michelle Coriddi, MD

646-608-8042

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Michelle Coriddi, MD

646-608-8042

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Michelle Coriddi, MD

646-608-8042

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Michelle Coriddi, MD

646-608-8042

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Michelle Coriddi, MD

646-608-8042

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Michelle Coriddi, MD

646-608-8042

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • immediate lymphatic reconstruction
  • axillary lymph node dissection
  • Lymphedema
  • Lymphedema Arm
  • Lymphedema of Upper Arm
  • Breast cancer
  • breast carcinoma
  • female breast cancer
  • Memorial Sloan Kettering Cancer Center
  • 23-303

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2025-11-10.