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

NCT ID: NCT01406769

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-16
• Study Completion Date: 2020-04-10

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Diagnostic (bioimpedance to measure lymphedema)

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.

Group Type: EXPERIMENTAL

Bioelectric Impedance Analysis

Intervention Type: PROCEDURE

Undergo preoperative and postoperative lower-extremity lymphedema assessment

Lymphadenectomy

Intervention Type: PROCEDURE

Undergo lymphadenectomy

Therapeutic Conventional Surgery

Intervention Type: PROCEDURE

Undergo radical vulvectomy or radical local excision

Interventions

Bioelectric Impedance Analysis

Undergo preoperative and postoperative lower-extremity lymphedema assessment

Intervention Type: PROCEDURE

Lymphadenectomy

Undergo lymphadenectomy

Intervention Type: PROCEDURE

Therapeutic Conventional Surgery

Undergo radical vulvectomy or radical local excision

Intervention Type: PROCEDURE

Other Intervention Names

BIA; Bioelectric Impedance; Bioelectric Impedance Test; Bioelectrical Impedance Analysis; Bioimpedance Analysis; excision of the lymph node; Lymph Node Dissection; lymph node excision

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay W Carlson

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

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

Countries

United States

Other Identifiers

NCI-2011-03798

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000706551

Identifier Type: -

Identifier Source: secondary_id

GOG-0269

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0269

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0269

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA101165

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0269

Identifier Type: -

Identifier Source: org_study_id