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

Phase 3

Active, not recruiting

• Conditions: Breast Cancer Lymphedema
• Interventions: Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction; Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction; Other: quality-of-life questionnaires; Other: measured by arm volume

• Registration Number: NCT04241341
• Lead Sponsor: 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-22
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
axillary lymph node dissection (ALND) without ILR	quality-of-life questionnaires	-
axillary lymph node dissection with ILR	measured by arm volume	-
axillary lymph node dissection with ILR	quality-of-life questionnaires	-
axillary lymph node dissection (ALND) without ILR	Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction	-
axillary lymph node dissection (ALND) without ILR	measured by arm volume	-
axillary lymph node dissection with ILR	Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction	-

Primary Outcome Measures

Name	Time	Method
the number of patients that had a decrease incidence of lymphedema	up to 2 years	as measured by arm volume will be a ≥10% increase in arm volume

Trial Locations

Locations (7)

Memorial Sloan Kettering Monmouth (Consent Only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent Only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Consent and Followup); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent Only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Consent only); 🇺🇸 Uniondale, New York, United States