This phase II trial studies bioimpedance spectroscopy in detecting lower-extremity lymphedema in patients with stage I, stage II, stage III, or stage IV vulvar cancer undergoing surgery and lymphadenectomy. Diagnostic procedures, such as bioimpedance spectroscopy, may help doctors to predict the onset of lower-extremity lymphedema in patients with vulvar cancer undergoing surgery.
OBJECTIVES: I. To evaluate the sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements to include circumferential volumetric measurements to detect lower-extremity lymphedema in patients who are undergoing an inguinal lymphadenectomy during the concurrent surgical management of a vulvar cancer. OUTLINE: This is a multicenter study. Patients undergo preoperative and postoperative lower-extremity lymphedema assessment comprising serial circumferential measurements, bioimpedance spectroscopy measurements, and clinical evaluation using the Stemmer sign. Patients undergo radical vulvectomy or radical local excision as prescribed by GOG-0244, and unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy. After completion of study, patients are followed up at 4-6 weeks, every 3 months for 1 year, and then every 6 months for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
Undergo preoperative and postoperative lower-extremity lymphedema assessment
Undergo lymphadenectomy
Undergo radical vulvectomy or radical local excision
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
M D Anderson Cancer Center
Houston, Texas, United States
...and 1 more locations
Sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements (limb volume and Stemmer Sign)
The usual assessment of sensitivity and specificity using the volume based diagnosis as the ?Gold Standard? after an receiver operating characteristic (ROC) analysis to determine the cut-point for the definition of a diagnosis of lymphedema by the bioimpedance method will be performed.
Time frame: Up to 24 months post-operatively
Frequency and severity of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.