Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection
Primary Purpose
Breast Cancer Lymphedema
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction
quality-of-life questionnaires
measured by arm volume
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Lymphedema focused on measuring Axillary Lymph Node Dissection, Lymphatic Reconstruction, 20-021
Eligibility 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 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
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (Consent and Followup)Recruiting
- Memorial Sloan Kettering Monmouth (Consent Only)Recruiting
- Memorial Sloan Kettering Bergen (Consent Only)Recruiting
- Memorial Sloan Kettering Commack (Consent only)Recruiting
- Memorial Sloan Kettering Westchester (Consent Only)Recruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Memorial Sloan Kettering Nassau (Consent only)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
axillary lymph node dissection with ILR
axillary lymph node dissection (ALND) without ILR
Arm Description
Outcomes
Primary Outcome Measures
the number of patients that had a decrease incidence of lymphedema
as measured by arm volume will be a ≥10% increase in arm volume
Secondary Outcome Measures
Full Information
NCT ID
NCT04241341
First Posted
January 22, 2020
Last Updated
August 21, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04241341
Brief Title
Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection
Official Title
A Randomized Controlled Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema
Keywords
Axillary Lymph Node Dissection, Lymphatic Reconstruction, 20-021
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
axillary lymph node dissection with ILR
Arm Type
Experimental
Arm Title
axillary lymph node dissection (ALND) without ILR
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
Intervention Description
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
Intervention Type
Procedure
Intervention Name(s)
Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction
Intervention Description
Current standard treatment at Memorial Sloan Kettering [MSK]).
Intervention Type
Other
Intervention Name(s)
quality-of-life questionnaires
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
measured by arm volume
Intervention Description
Bilateral arm volumes will be measured with sequential circumferential measurements with the truncated cone formula. If a patient cannot return to Manhattan for these assessments but is seen by a lymphedema therapist in a regional location or at an institution outside of MSK as part of their routine cancer treatment, this data can be used in the final analysis
Primary Outcome Measure Information:
Title
the number of patients that had a decrease incidence of lymphedema
Description
as measured by arm volume will be a ≥10% increase in arm volume
Time Frame
up to 2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breast Cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Coriddi, MD
Phone
646-608-8042
Email
coriddim@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Babak Mehrara, MD
Phone
212-639-3099
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Coriddi, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent and Followup)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Coriddi, MD
Phone
646-608-8042
Facility Name
Memorial Sloan Kettering Monmouth (Consent Only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Coriddi, MD
Phone
646-608-8042
Facility Name
Memorial Sloan Kettering Bergen (Consent Only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Coriddi, MD
Phone
646-608-8042
Facility Name
Memorial Sloan Kettering Commack (Consent only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Coriddi, MD
Phone
646-608-8042
Facility Name
Memorial Sloan Kettering Westchester (Consent Only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Coriddi, MD
Phone
646-608-8042
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Coriddi, MD
Phone
646-608-8042
Facility Name
Memorial Sloan Kettering Nassau (Consent only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Coriddi, MD
Phone
646-608-8042
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection
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