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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female sex

Diagnosis of breast cancer

Ages 18 to 75 years

Consented for unilateral ALND or for unilateral SLNB with possible ALND

Disqualifiers

Male sex

Does not speak English

Does not fit into study garment

Axillary recurrence

Trial design

Design model

Single group

Treatments tested in this trial

  • Immediate Lymphatic Reconstruction

    Procedure/Surgery

    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 intervention

    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 intervention

    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 intervention

    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

Treatment groups

285 Participants
are divided into 1 treatment group
Group A: Participants with Breast CancerExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

The difference between the baseline and postoperative arm volume measurement

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

Time frame
Up to 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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