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

Gynecologic Oncology Group (GOG)

Status and phase

Completed

Phase 2

Conditions

Stage IIIC Vulvar Cancer AJCC v7

Stage IIIA Vulvar Cancer AJCC v7

Stage II Vulvar Cancer AJCC v7

Stage IB Vulvar Cancer AJCC v7

Perioperative/Postoperative Complications

Lymphedema

Stage IVB Vulvar Cancer AJCC v6 and v7

Stage IIIB Vulvar Cancer AJCC v7

Stage IVA Vulvar Cancer AJCC v7

Stage IA Vulvar Cancer AJCC v7

Treatments

Procedure: Bioelectric Impedance Analysis

Procedure: Therapeutic Conventional Surgery

Procedure: Lymphadenectomy

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT01406769

CDR0000706551

NCI-2011-03798 (Registry Identifier)

U10CA101165 (U.S. NIH Grant/Contract)

GOG-0269 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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