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

Recruiting

• Conditions: Lymphedema
• Interventions: Behavioral: Quality of Life Assessments

• Registration Number: NCT03248310
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-09
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-surgical treatment	Quality of Life Assessments	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.
vascularized lymph node transfer (VLNT)	Quality of Life Assessments	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.

Primary Outcome Measures

Name	Time	Method
Quality of Life	up to 40 months	Questionnaire to assess quality of life changes

Trial Locations

Locations (3)

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

Memorial Sloan Kettering Nassau (Limited Protocol Activites); 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 West Harrison, New York, United States