Recruiting

Surgical Treatment vs. Non-Surgical Management

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT03248310

Conditions

Lymphedema

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Quality of Life Assessments

Study Details

Brief 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

Lymphedema

Study ID

NCT03248310

Start date

Aug 9, 2017

Status verified date

Sep, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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:

  • 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

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Quality of Life Assessments

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

Primary outcome measure

  • Quality of Life [ Time Frame: up to 40 months ]

Central Contacts and Locations

Central contacts

Babak Mahrara, MD

646-608-8085mehrarab@MSKCC.ORG

Andrea Barrio, MD

646-888-5118

Locations

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Babak Mahrara, MD

646-608-8085

Andrea Barrio, MD

646-888-5118

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Babak Mahrara, MD

646-608-8085

Andrea Barrio, MD

646-888-5118

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Babak Mahrara, PhD

646-608-8085

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • Quality of Life (QoL)
  • 17-377

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2025-09-22.