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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01406769
First received: July 29, 2011
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Lymphedema
Perioperative/Postoperative Complications
Stage IA Vulvar Cancer
Stage IB Vulvar Cancer
Stage II Vulvar Cancer
Stage IIIA Vulvar Cancer
Stage IIIB Vulvar Cancer
Stage IIIC Vulvar Cancer
Stage IVA Vulvar Cancer
Stage IVB Vulvar Cancer
Procedure: bioimpedance spectroscopy
Procedure: therapeutic conventional surgery
Procedure: lymphadenectomy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of a Vulvar Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements (limb volume and Stemmer Sign) [ Time Frame: Up to 24 months post-operatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: bioimpedance spectroscopy
Undergo preoperative and postoperative lower-extremity lymphedema assessment
Other Name: BIS
Procedure: therapeutic conventional surgery
Undergo radical vulvectomy or radical local excision
Procedure: lymphadenectomy
Undergo lymphadenectomy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406769

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
United States, Minnesota
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute - South Yale
Tulsa, Oklahoma, United States, 74136
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Jay Carlson Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01406769     History of Changes
Other Study ID Numbers: GOG-0269, NCI-2011-03798, CDR0000706551, GOG-0269, GOG-0269, GOG-0269, U10CA101165
Study First Received: July 29, 2011
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphedema
Postoperative Complications
Vulvar Neoplasms
Lymphatic Diseases
Pathologic Processes
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014