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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04241341

Collaborator

(none)

174

Enrollment

Locations

Arms

35.3

Anticipated Duration (Months)

24.9

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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]).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 :

Jan 22, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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 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 sequential circumferential measurements with the truncated cone formula.

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 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

Other: measured by arm volume

Bilateral arm volumes will be measured with sequential circumferential measurements with the truncated cone formula.

Outcome Measures

Primary Outcome Measures

the number of patients that had a decrease incidence of lymphedema [2 years]
as measured by arm volume will be a ≥10% increase in arm volume

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 OR a high likelihood of ALND per the Breast Surgeon
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge (Consent and Followup)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Consent Only)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Consent Only)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack (Consent only)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (Consent Only)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Consent only)	Uniondale	New York	United States	11553