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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06144164

Collaborator

(none)

285

Enrollment

Locations

Arm

Anticipated Duration (Months)

40.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphedema Lymphedema Arm Lymphedema of Upper Arm Breast Cancer Breast Carcinoma Female Breast Cancer	Procedure: Immediate Lymphatic Reconstruction Diagnostic Test: Volumetric arm measurements Other: Lymphatic massage Other: Range of motion exercises Other: Compression garment use	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

285 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 16, 2023

Anticipated Primary Completion Date :

Mar 16, 2030

Anticipated Study Completion Date :

Mar 16, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with Breast Cancer Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.	Procedure: Immediate Lymphatic Reconstruction Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection Other Names: ILR 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 Other: 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 Other: 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

Arm

Intervention/Treatment

Experimental: Participants with Breast Cancer

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

Procedure: Immediate Lymphatic Reconstruction

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

Other Names:

ILR

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

Other: Range of motion exercises

Other: 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack (Limited Protocol Activities)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York	United States	11553