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

Phase 2

Completed

• Conditions: Stage IB Vulvar Cancer AJCC v7; Perioperative/Postoperative Complications; Stage IVA Vulvar Cancer AJCC v7; Stage IA Vulvar Cancer AJCC v7; Stage II Vulvar Cancer AJCC v7; Stage IIIA Vulvar Cancer AJCC v7; Stage IIIB Vulvar Cancer AJCC v7; Stage IVB Vulvar Cancer AJCC v6 and v7; Lymphedema; Stage IIIC Vulvar Cancer AJCC v7
• Interventions: Procedure: Bioelectric Impedance Analysis; Procedure: Lymphadenectomy; Procedure: Therapeutic Conventional Surgery

• Registration Number: NCT01406769
• Lead Sponsor: Gynecologic Oncology Group

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-07-29
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-01
• Study Start: 2012-07-16
• Primary Completion: 2020-04-10
• Study Completion: 2020-04-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (bioimpedance to measure lymphedema)	Bioelectric Impedance Analysis	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.
Diagnostic (bioimpedance to measure lymphedema)	Lymphadenectomy	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.
Diagnostic (bioimpedance to measure lymphedema)	Therapeutic Conventional Surgery	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements (limb volume and Stemmer Sign)	Up to 24 months post-operatively	The usual assessment of sensitivity and specificity using the volume based diagnosis as the ?Gold Standard? after an receiver operating characteristic (ROC) analysis to determine the cut-point for the definition of a diagnosis of lymphedema by the bioimpedance method will be performed.
Frequency and severity of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0	Up to 24 months

Trial Locations

Locations (11)

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Women's Cancer Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

University of Minnesota/Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, 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

Mercy Hospital Springfield; 🇺🇸 Springfield, Missouri, United States

Oklahoma Cancer Specialists and Research Institute-Tulsa; 🇺🇸 Tulsa, Oklahoma, United States