RecruitingNCT03248310Updated Sep 24, 2026

A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management

An observational study in Lymphedema, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 600
Ages: 18 Years to 80 Years
Sex: All

Study summary

This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.

Conditions studied

Lymphedema

Browse trials for

Lymphedema 560

Keywords

Quality of Life (QoL)
17-377

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Sampling method: Non-probability sample

Study population

Patients who present for consultation of their lymphedema and who meet eligibility criteria will be offered the option of enrolling in this study at the time of their initial consultation.

Inclusion criteria

Patients aged 18-80 years
Primary and secondary lymphedema of the upper or lower extremity
International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema
Proficiency in English language

Exclusion criteria

Exclusion Criteria:

Patients with clotting disorders, venous insufficiency, end-stage lymphedema unless they are on the non-surgical arm.
Additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 600 participants (estimated)
Patient registry: No

Groups and cohorts

vascularized lymph node transfer (VLNT)
This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
Behavioral: Quality of Life Assessments
non-surgical treatment
This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
Behavioral: Quality of Life Assessments

Interventions

BehavioralQuality of Life Assessments
Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.

What researchers measure

Primary outcomes

Quality of Life
Questionnaire to assess quality of life changes
Time frame: up to 40 months

Study locations

3 of 3 sites recruiting

Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604, United States
- Babak Mahrara, MD · Contact · 646-608-8085
- Andrea Barrio, MD · Contact · 646-888-5118
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065, United States
- Babak Mahrara, MD · Contact · 646-608-8085
- Andrea Barrio, MD · Contact · 646-888-5118
Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York 11553, United States
- Babak Mahrara, PhD · Contact · 646-608-8085
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

Registry details

Key details

Study ID: NCT03248310
Lead sponsor: Memorial Sloan Kettering Cancer Center
Responsible party: Sponsor
First posted: Aug 14, 2017
Start date: Aug 9, 2017
Primary completion: Aug 2027 (estimated)
Completion: Aug 2027 (estimated)
Last update: Sep 24, 2026

Study contacts

Babak Mahrara, MD

Contact

mehrarab@MSKCC.ORG

646-608-8085

Andrea Barrio, MD

Contact

646-888-5118

Babak Mahrara, MD

principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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