Clinical trial NCT01406769: 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
Official title: A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of a Vulvar Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements (limb volume and Stemmer Sign)
timeFrame: Up to 24 months post-operatively
measure: Frequency and severity of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Indianapolis
country: United States
facility: Indiana University/Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Saint Vincent Hospital and Health Care Center
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota/Masonic Cancer Center
state: Minnesota
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute-Tulsa
state: Oklahoma
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: Gynecologic Oncology Group
name: Jay W Carlson
role: PRINCIPAL_INVESTIGATOR
References: