Blood and Lymph Conditions

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Lymphedema

Breast Neoplasms

Carcinoma

Breast Diseases

Skin Diseases

Lymphatic Diseases

Quality of Life

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

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

Immediate Lymphatic Reconstruction

Volumetric arm measurements will occur at each in-person postoperative visit time points.

Volumetric arm measurements

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

Lymphatic massage

Range of motion exercises

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

Compression garment use

Michelle Coriddi, MD

Joseph Dayan, MD

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.

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

A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Breast Cancer Lymphedema

Postoperative Complications

Breast cancer patients receiving axillary lymph node dissection and immediate lymphatic reconstruction

Breast cancer patients receiving only axillary lymph node dissection

Breast cancer patients receive axillary lymph node dissection and immediate lymphatic reconstruction

Immediate lymphatic reconstruction

Hao-Chih Dai, MD, PhD

Breast cancer-related lymphedema (BCRL) is a debilitating, usually lifelong burden for breast cancer survivors. For the breast cancer patients receiving axillary lymph node dissection (ALND), the likelihood of BCRL is about 20%. Lymphatico-venous anastomosis (LVA) has been accepted as a method of treating extremity lymphedema. A few studies have mentioned the prophylactic effect of LVA on BCRL. However, there is still lack of a large-scale randomized controlled trial to corroborate its efficacy. Therefore, the goal of this study is to conduct a prospective randomized controlled trial to evaluate if immediate lymphatic reconstruction (ILR) with LVA could have a clinically significant effect on the reduction of BCRL occurrence.

Can ILR Reduce the Risk of Arm Lymphedema?

Can Immediate Lymphatic Reconstruction With Lymphatico-Venous Anastomosis Reduce the Occurrence of Arm Lymphedema in Breast Cancer Patients After Axillary Lymph Node Dissection? A Prospective Randomized Controlled Trial.

Non-identifiable data will be shared upon request

Patient reported outcome measures by LYMPH-Q Upper Extremity Module

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer	NCT06144164	Lymphedema Lymphedema Arm Lymphedema of U... Breast Cancer Breast Carcinom... Female Breast C...	Immediate Lymph... Volumetric arm ... Lymphatic massa... Range of motion... Compression gar...	18 Years - 75 Years	Memorial Sloan Kettering Cancer Center
Can ILR Reduce the Risk of Arm Lymphedema?	NCT05742945	Breast Cancer L...	Immediate lymph...	20 Years - 75 Years	National Taiwan University Hospital

Spots Global Cancer Trial Database for immediate lymphatic reconstruction