Actively Recruiting
A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-09-22
600
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term quality of life outcomes in patients with lymphedema who either choose to have surgery using vascularized lymph node transfer (VLNT) or opt for non-surgical management. The study aims to compare these two groups to better understand the impact of surgical versus non-surgical treatment on patient well-being. This observational study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on adults with primary or secondary lymphedema affecting the upper or lower limbs. Participants are divided into two groups based on their treatment choice: those who undergo VLNT surgery and those who receive non-surgical care. There is no additional treatment or intervention during the study follow-up period; the research simply observes and assesses quality of life over time. The study uses established questionnaires such as the Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale version 2 (LLISv2), and LYMQOL-Leg to evaluate patient outcomes. During the study, participants complete quality of life assessments up to 40 months after enrollment. There are no therapeutic procedures administered as part of the study itself. The research team monitors patient responses to these questionnaires to measure the impact of different treatment choices on daily living and overall health. The study includes adults between 18 and 80 years old who speak English and meet specific lymphedema stage criteria.
CONDITIONS
Brief Title
A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years
- Primary or secondary lymphedema of the upper or lower extremity
- International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema
- Proficiency in English language
You will not qualify if you...
- Patients with clotting disorders, venous insufficiency, or end-stage lymphedema unless they are on the non-surgical arm
- Patients who refuse to complete questionnaires may be excluded and replaced at the investigators' discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 40 months
Participants are observed over time to assess quality of life related to their lymphedema treatment choice without receiving a therapeutic intervention during follow-up.
Trial Site Locations
Total: 3 locations
1
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
3
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
B
Babak Mahrara, MD
A
Andrea Barrio, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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