This study assesses the quality of life in patients with secondary lymphedema who are undergoing surgery or non-surgical treatment. Having surgery for secondary lymphedema may have good effects on patients’ self-reported quality of life, limb measurements, and may change the lymphatic system such as to increase number of new, healthy lymphatic vessels.
Additional locations may be listed on ClinicalTrials.gov for NCT03248310.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Babak Mehrara
Phone: 646-608-8085
West Harrison
Memorial Sloan Kettering WestchesterStatus: Active
Contact: Babak Mehrara
Phone: 646-608-8085
PRIMARY OBJECTIVES:
I. To evaluate changes in lymphedema-specific quality of life (QOL) in patients undergoing vascularized lymph node transfer (VLNT), liposuction or lymphaticovenular bypass (LVB) to treat lymphedema.
SECONDARY OBJECTIVES:
I. To evaluate changes in lymphedema-specific QOL over time in patients undergoing non-surgical treatment for lymphedema.
II. To evaluate if limb volume and physiologic (indocyanine green [ICG] lymphangiography, bioimpedance) findings correlate with lymphedema-specific QOL.
EXPLORATORY OBJECTIVES:
I. To explore potential differences in lymphedema-specific QOL changes between patients undergoing VLNT/ liposuction/ LVB and those undergoing non-surgical treatment for lymphedema.
II. To evaluate if lymphedema-specific QOL correlates with skin properties and histologic changes from non-invasive skin measurements and optional skin biopsies at initial/baseline consultation and at 1-2 years post-consultation. To evaluate trans-epidermal water loss in lymphedema patients by optionally obtaining skin cells via non-invasive messenger ribonucleic acid (mRNA) based tape stripping.
III. To estimate minimally important differences (MIDs) for the lymphedema-specific QOL measures using clinical anchors.
OUTLINE: This is an observational study.
Patients undergo observation and complete quality of life questionnaire assessment and may also optionally undergo biopsy on study.
After completion of study, patients are followed up periodically.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorBabak Mehrara