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
A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of a Vulvar Cancer
4 other identifiers
interventional
120
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2012
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 1, 2011
CompletedStudy Start
First participant enrolled
July 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2020
CompletedMay 7, 2021
May 1, 2021
7.7 years
July 29, 2011
May 4, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Frequency and severity of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Up to 24 months
Study Arms (1)
Diagnostic (bioimpedance to measure lymphedema)
EXPERIMENTALPatients 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.
Interventions
Undergo preoperative and postoperative lower-extremity lymphedema assessment
Undergo lymphadenectomy
Undergo radical vulvectomy or radical local excision
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (11)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay W Carlson
Gynecologic Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2011
First Posted
August 1, 2011
Study Start
July 16, 2012
Primary Completion
April 10, 2020
Study Completion
April 10, 2020
Last Updated
May 7, 2021
Record last verified: 2021-05