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

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 3
Age range: 18 years - 75 years
Sex eligible: Female
Healthy volunteers: Not accepted
Participants: 285 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

Participants with Breast Cancer

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

Procedure: Immediate Lymphatic Reconstruction · Diagnostic Test: Volumetric arm measurements · Other: Lymphatic massage · Other: Range of motion exercises · Other: Compression garment use

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

The difference between the baseline and postoperative arm volume measurement

Time frame: 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

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (7)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

7 locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey, United StatesRecruiting