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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Lymphedema

Treatments: Behavioral: Quality of Life Assessments

Study type: Observational

Funder types: Other

Identifiers

NCT03248310

17-377

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 2 patient groups

vascularized lymph node transfer (VLNT)

Description:

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.

Treatment:

Behavioral: Quality of Life Assessments

non-surgical treatment

Description:

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.

Treatment:

Behavioral: Quality of Life Assessments