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Preventing Lymphedema in Axillary Lymph Node Dissection

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ClinicalTrials.gov Identifier: NCT03428581
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
James W. Jakub, Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphedema Breast Cancer Melanoma Procedure: ALND with ARM +/- LVB Procedure: ALND Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arms and Interventions
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Arm Intervention/treatment
Experimental: ALND with ARM +/- LVB
Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.
 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.
Active Comparator: ALND without ARM +/- LVB
Axillary Lymph Node Dissection (ALND)
 Procedure: ALND
Prospective and retrospective subjects undergoing an ALND.


Outcome Measures
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Primary Outcome Measures :
  1. Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity [ Time Frame: 36 months following surgery ]
    Bilateral Limb volume measurements

  2. Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity [ Time Frame: 36 months following surgery ]
    Validated patient reported surveys


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428581


Contacts
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Contact: Sheri Ramaker, R.N. 507-538-6984 ramaker.sheri@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sheri Ramaker, R.N.    507-538-6984    ramaker.sheri@mayo.edu   
Principal Investigator: James Jakub, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: James W Jakub Mayo Clinic
More Information
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Additional Information:

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Responsible Party: James W. Jakub, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03428581    
Other Study ID Numbers: 16-010491
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James W. Jakub, Mayo Clinic:
Axillary
Lymph node
Dissection
 Reverse Mapping
Lympho-venous Bypass (LVB)
Axillary Reverse Mapping (ARM)
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases