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NCT03248310 Clinical Trial

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

Lymphedema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03248310
Other study ID # 17-377
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 9, 2017
Est. completion date August 2024

Study information
Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact Babak Mahrara, MD
Phone 646-608-8085
Email mehrarab@MSKCC.ORG
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Limited Protocol Activites) Rockville Centre New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of Life Questionnaire to assess quality of life changes up to 40 months
See also
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Terminated NCT01580800 - National Breast Cancer and Lymphedema Registry
Suspended NCT05366699 - LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy N/A
Completed NCT06249360 - Lymphatic System Reflux After Lymphatic Operation
Completed NCT06220903 - The Effect of Complex Decongestive Therapy in Patients With Lymphedema N/A
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