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Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241341
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

The researchers are doing this study to see if having immediate lymphatic reconstruction after axillary lymph node dissection (ALND) can decrease the development of lymphedema, a side effect of ALND. Other purposes of the study include:

Comparing the approach of immediate lymphatic reconstruction after ALND with the approach of ALND alone Looking at whether having immediate lymphatic reconstruction after ALND improves a person's quality of life Seeing if adding standard of care radiation therapy to either study approach (immediate lymphatic reconstruction after ALND or ALND alone) has an effect on development of lymphedema


Condition or disease Intervention/treatment Phase
Breast Cancer Lymphedema Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction Other: quality-of-life questionnaires Other: measured by arm volume Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomized to one of two groups:

ALND with ILR (intervention group) and ALND without ILR (control group; current standard treatment at Memorial Sloan Kettering [MSK]).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: axillary lymph node dissection with ILR Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction

Other: quality-of-life questionnaires
Four validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Anxiety Inventory (BAI). Study participants will undergo standard lymphedema measurements and quality-of-life questionnaires at baseline before ALND and postoperatively at 6 weeks (+/- 30 days) and at 6, 12, 18, and 24 months (+/- 30 days). If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them.

Other: measured by arm volume
Bilateral arm volumes will be measured with perometry which uses infrared light to scan an image of the limb, and sequential circumferential measurements with the truncated cone formula.

Active Comparator: axillary lymph node dissection (ALND) without ILR Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction
Current standard treatment at Memorial Sloan Kettering [MSK]).

Other: quality-of-life questionnaires
Four validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Anxiety Inventory (BAI). Study participants will undergo standard lymphedema measurements and quality-of-life questionnaires at baseline before ALND and postoperatively at 6 weeks (+/- 30 days) and at 6, 12, 18, and 24 months (+/- 30 days). If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them.

Other: measured by arm volume
Bilateral arm volumes will be measured with perometry which uses infrared light to scan an image of the limb, and sequential circumferential measurements with the truncated cone formula.




Primary Outcome Measures :
  1. the number of patients that had a decrease incidence of lymphedema [ Time Frame: 2 years ]
    as measured by arm volume will be a ≥10% increase in arm volume



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast Cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female breast cancer patients 18-75 years of age
  • Patients consenting for unilateral ALND (prior history of SLNBx allowed if <6 months from consent) OR patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node
  • Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery

Exclusion Criteria:

  • Male breast cancer patients
  • Non-English speaking participants
  • Female breast cancer patients with axillary recurrence
  • Female breast cancer patients who have a history of ALND
  • Female patients requiring bilateral ALND for the treatment of their breast cancer
  • Female breast patients treated with SLNBx only
  • Known allergy to dye used in ILR

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): NCT04241341


Contacts
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Contact: Michelle Coriddi, MD 646-608-8042 coriddim@mskcc.org
Contact: Babak Mehrara, MD 212-639-3099

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent Only) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Michelle Coriddi, MD    646-608-8042      
Memoral Sloan Kettering Monmouth (Consent Only) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Michelle Coriddi, MD    646-608-8042      
Memorial Sloan Kettering Bergen (Consent Only) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Michelle Coriddi, MD    646-608-8042      
United States, New York
Memoral Sloan Kettering Westchester (Consent Only) Recruiting
Harrison, New York, United States, 10604
Contact: Michelle Coriddi, MD    646-608-8042      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michelle Coriddi, MD    646-608-8042      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Michelle Coriddi, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04241341    
Other Study ID Numbers: 20-021
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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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 Memorial Sloan Kettering Cancer Center:
Axillary Lymph Node Dissection
Lymphatic Reconstruction
20-021
Additional relevant MeSH terms:
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Lymphedema
Breast Cancer Lymphedema
Lymphatic Diseases
Postoperative Complications
Pathologic Processes