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

NCT06144164 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2025-11-10

No results posted yet for this study

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
  • Female Breast Cancer

Interventions

PROCEDURE

Immediate Lymphatic Reconstruction

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

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

Sponsors & Collaborators

Principal Investigators

  • Michelle Coriddi, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2030-03-16
Completion
2030-03-16

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06144164 on ClinicalTrials.gov