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:

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.

Inclusion Criteria:

- Patients with vulvar cancer already enrolled onto Gynecologic Oncology Group
(GOG)-0244 who will undergo or have undergone 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 going to receive multi-modality therapy (radiation +/-
chemotherapy) after undergoing surgery are eligible

- Patients who have met the pre-entry requirements

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information for GOG-0269 and for GOG-0244

- Patients may undergo sentinel node mapping as long as it is followed by a full
lymphadenectomy during the same operative event

- Serum Albumin level of >= 3.0 within 14 days of entry

- Patients with a GOG performance status of 0, 1, or 2

Exclusion Criteria:

- Patients not enrolled onto GOG-0244

- Patients with any prior clinical history of lower extremity lymphedema

- Patients who have a history of congestive heart failure, chronic renal disease, or
chronic liver disease

- Patients with a prior history of chronic lower extremity swelling

- Patients with a GOG Performance Grade of 3 or 4

- 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

- Patients who have had prior lower extremity vascular surgery (arterial or venous)

- Patients who have had prior pelvic bilateral axillary or any pelvic, abdominal,
inguinal, or lower extremity radiation therapy

- Patients who are going to receive another elective surgery during the same operative
event as their inguinal lymphadenectomy and vulvar surgery

- Patients who undergo sentinel node biopsy without the intention of undergoing a
complete lymphadenectomy during that same operative event

- Patients with an implanted cardiac device such as a pacemaker or implantable
cardioverter defibrillator

- Patients who are pregnant or currently breastfeeding

- Patients who have been treated for, or are at risk of, bilateral arm lymphedema

- Patients with an allergic reaction to electrocardiogram (EKG) electrodes

- Patients who have had bilateral auxiliary dissection