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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06144164
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 16, 2023
Status verified
Nov 2025
Primary completion
Mar 16, 2030
Completion
Mar 16, 2030

Study Design

Enrollment
285 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Participants with Breast Cancer
    Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.

Primary Outcome Measure

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

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Michelle Coriddi, MD
646-608-8042
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Michelle Coriddi, MD
646-608-8042
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Michelle Coriddi, MD
646-608-8042
Memorial Sloan Kettering Commack (Limited Protocol Activities)CommackNew York11725
Michelle Coriddi, MD
646-608-8042
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Michelle Coriddi, MD
646-608-8042
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Michelle Coriddi, MD
646-608-8042
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Michelle Coriddi, MD
646-608-8042

Find similar trials in Basking Ridge, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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