Trial Title:
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People with Breast Cancer
NCT ID:
NCT06144164
Condition:
Lymphedema
Lymphedema Arm
Lymphedema of Upper Arm
Breast Cancer
Breast Carcinoma
Female Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Conditions: 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
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Immediate Lymphatic Reconstruction
Description:
Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node
Dissection
Arm group label:
Participants with Breast Cancer
Other name:
ILR
Intervention type:
Diagnostic Test
Intervention name:
Volumetric arm measurements
Description:
Volumetric arm measurements will occur at each in-person postoperative visit time points.
Arm group label:
Participants with Breast Cancer
Intervention type:
Other
Intervention name:
Lymphatic massage
Description:
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
Arm group label:
Participants with Breast Cancer
Intervention type:
Other
Intervention name:
Range of motion exercises
Description:
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
Arm group label:
Participants with Breast Cancer
Intervention type:
Other
Intervention name:
Compression garment use
Description:
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 group label:
Participants with 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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle Coriddi, MD
Phone:
646-608-8042
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle Coriddi, MD
Phone:
646-608-8042
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle Coriddi, MD
Phone:
646-608-8042
Facility:
Name:
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle Coriddi, MD
Phone:
646-608-8042
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle Coriddi, MD
Phone:
646-608-8042
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle Coriddi, MD
Phone:
646-608-8042
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle Coriddi, MD
Phone:
646-608-8042
Start date:
November 16, 2023
Completion date:
March 16, 2030
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06144164
http://www.mskcc.org
