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

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Brief Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements (limb volume and Stemmer Sign)


Condition

Lymphedema

Intervention

Bioelectric Impedance Analysis

Study Arms / Comparison Groups

 Diagnostic (bioimpedance to measure lymphedema)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

120

Start Date

July 16, 2012

Completion Date

April 10, 2020

Primary Completion Date

April 10, 2020

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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jay W Carlson, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01406769

Organization ID

GOG-0269

Secondary IDs

NCI-2011-03798

Responsible Party

Sponsor

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Jay W Carlson, Principal Investigator, Gynecologic Oncology Group


Verification Date

May 2021