Status:
COMPLETED
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
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphedema
Perioperative/Postoperative Complications
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 lymphadene...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01406769
Start Date
July 16 2012
End Date
April 10 2020
Last Update
May 7 2021
Active Locations (11)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
3
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
4
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455