Preventing Lymphedema in Axillary Lymph Node Dissection

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Preventing Lymphedema in Axillary Lymph Node Dissection

Study Purpose

The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	Female

More Inclusion & Exclusion Criteria

Inclusion Criteria.

- Patients scheduled to undergo an axillary lymph node dissection.

- Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings.

- English speaking.

Exclusion Criteria.

- Prior ipsilateral axillary lymph node dissection.

- Prior ipsilateral axillary radiation.

- Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement.

- Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.

- Pregnant patients cannot participate in the substudy

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03428581
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	James W Jakub, MDMara A. Piltin, DO
Principal Investigator Affiliation	Mayo ClinicMayo Clinic in Rochester
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lymphedema, Breast Cancer, Melanoma
Study Website:	View Trial Website

Additional Details

All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.

Arms & Interventions

Arms

Experimental: ALND with ARM +/- LVB

Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.

Active Comparator: ALND without ARM +/- LVB

Axillary Lymph Node Dissection (ALND)

Interventions

Procedure: - ALND with ARM +/- LVB

Subjects will undergo removal of the lymph nodes in the underarm or "axilla" area. This is referred to as an axillary lymph node dissection (ALND). The procedure for identifying the drainage of the arm lymphatics during an axillary dissection has been coined axillary reverse mapping (ARM). Lympho-venous bypass (LVB) is a technique incorporated along with the ARM procedure that allows preservation of the lymphatics draining the arm while removing the standard lymph nodes and not compromising the extent of the axillary dissection.

Procedure: - ALND

Prospective and retrospective subjects undergoing an ALND.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Florida, Jacksonville 4160021, Florida 4155751

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Address

Mayo Clinic in Florida

Jacksonville 4160021, Florida 4155751, 32224

Mayo Clinic in Rochester, Rochester 5043473, Minnesota 5037779

Status

Address

Mayo Clinic in Rochester

Rochester 5043473, Minnesota 5037779, 55905

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