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

• 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 ]

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.

OBJECTIVES:

• 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.

• Lymphedema
• Perioperative/Postoperative Complications
• Vulvar Cancer

• Procedure: assessment of therapy complications
• Procedure: bioimpedance spectroscopy
• Procedure: lymphadenectomy
• Procedure: therapeutic conventional surgery

DISEASE CHARACTERISTICS:

• Patients with vulvar cancer already enrolled onto GOG-0244 who will undergo definitive surgery for primary stage I-IV vulvar cancer who will receive a radical vulvectomy or radical local excision with concurrent unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy;

  • Patients who are undergoing unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy and will receive multi-modality therapy (radiation +/- chemotherapy) after undergoing surgery are eligible
  • Patients may undergo sentinel node mapping as long as it is followed by a full lymphadenectomy during the same operative event
• No patients with any prior clinical lower-extremity lymphedema

PATIENT CHARACTERISTICS:

• Patients with a GOG performance status of 0, 1, or 2
• Patients must have a serum albumin level of ≥ 3.0 g/dL within 14 days of entry
• No patients who have a history of congestive heart failure, chronic renal disease, or chronic liver disease
• No history of chronic lower-extremity swelling
• No patients with a history of other invasive malignancies if that malignancy included a bilateral lymph node procedure (example: bilateral mastectomies and axillary lymphadenectomies), or if their previous cancer treatment included any of the surgical procedures
• No patients who are pregnant or currently breastfeeding
• No patients with an allergic reaction to EKG electrodes

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No patients who have had prior lower-extremity vascular surgery (arterial or venous) or any inguinal, hip, knee, or ankle surgery, including orthopedic procedures
• No patients who have had prior pelvic bilateral axillary or any pelvic, abdominal, inguinal, or lower-extremity radiation therapy
• No patients who are going to receive another elective surgery during the same operative event as their inguinal lymphadenectomy and vulvar surgery
• No patients with an implanted cardiac device such as a pacemaker or implantable cardioverter defibrillator
• No patients who have been treated for, or are at risk of, bilateral arm lymphedema
• No patients who have had bilateral auxiliary dissection