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

Lymphedema Clinical Trial

Official title:

A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of a Vulvar Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406769
• Other study ID #: GOG-0269
• Secondary ID: NCI-2011-03798CD
• Status: Completed
• Phase: Phase 2
• Start date: July 16, 2012
• Est. completion date: April 10, 2020

Study information

• Verified date: May 2021
• Source: GOG Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 10, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema
• Perioperative/Postoperative Complications
• Postoperative Complications
• 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
• Vulvar Neoplasms

Intervention

Procedure:
• Bioelectric Impedance Analysis
Undergo preoperative and postoperative lower-extremity lymphedema assessment
• Lymphadenectomy
Undergo lymphadenectomy
• Therapeutic Conventional Surgery
Undergo radical vulvectomy or radical local excision

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	M D Anderson Cancer Center	Houston	Texas
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	Women's Cancer Center of Nevada	Las Vegas	Nevada
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements (limb volume and Stemmer Sign)	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.	Up to 24 months post-operatively
Primary	Frequency and severity of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0		Up to 24 months