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

July 29, 2011
August 8, 2014
July 2012
July 2017   (final data collection date for primary outcome measure)
  • 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 ]
  • Sensitivity, specificity, and feasibility of bioimpedance technology compared to current techniques in measuring lower-extremity lymphedema in patients undergoing surgery for vulvar cancer [ Designated as safety issue: No ]
  • Frequency and severity of adverse events using CTCAE v4.0 [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01406769 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • 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
    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
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.
Interventions:
  • Procedure: bioimpedance spectroscopy
  • Procedure: therapeutic conventional surgery
  • Procedure: lymphadenectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
Not Provided
July 2017   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01406769
GOG-0269, NCI-2011-03798, CDR0000706551, GOG-0269, GOG-0269, GOG-0269, U10CA101165
Yes
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Jay Carlson Gynecologic Oncology Group
Gynecologic Oncology Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP