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
RATIONALE: Diagnostic procedures, such as bioimpedance spectroscopy, may help doctors to predict the onset of lower-extremity lymphedema in patients with vulvar cancer undergoing surgery.
PURPOSE: 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.
Procedure: assessment of therapy complications
Procedure: bioimpedance spectroscopy
Procedure: therapeutic conventional surgery
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of Vulvar Cancer|
- Sensitivity, specificity, and feasibility of bioimpedance technology compared to current techniques in measuring lower-extremity lymphedema in patients undergoing surgery for vulvar cancer [ Designated as safety issue: No ]
- Frequency and severity of adverse events using CTCAE v4.0 [ Designated as safety issue: Yes ]
|Study Start Date:||July 2012|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
- 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.
|United States, Missouri|
|Mercy-Springfield, Cancer Research Ctr. for the Ozarks||Recruiting|
|Springfield, Missouri, United States, 65804|
|Contact: Jay W Carlson, DO email@example.com|
|Study Chair:||Jay W. Carlson, DO||Saint John's Physicians and Clinics|