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

Completed · Phase 2

Conditions studied: Lymphedema, Perioperative/Postoperative Complications, Stage IA Vulvar Cancer AJCC v7, Stage IB Vulvar Cancer AJCC v7, Stage II Vulvar Cancer AJCC v7, Stage IIIA Vulvar Cancer AJCC v7, Stage IIIB Vulvar Cancer AJCC v7, Stage IIIC Vulvar Cancer AJCC v7, Stage IVA Vulvar Cancer AJCC v7, Stage IVB Vulvar Cancer AJCC v6 and v7

In brief

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.

Key facts

Study ID

NCT01406769

Run by

Gynecologic Oncology Group

People needed

120

Starts

2012-07-16

Expected to finish

2020-04-10

Last updated by the study team

2021-05-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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