Trial record 15 of 107 for:    Vulvar Cancer: Clinical Trials

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 currently recruiting participants.
Verified December 2012 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01406769
First received: July 29, 2011
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

RATIONALE: Diagnostic procedures, such as bioimpedance spectroscopy, may help doctors to predict the onset of lower-extremity lymphedema in patients with vulvar cancer undergoing surgery.

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.


Condition Intervention Phase
Lymphedema
Perioperative/Postoperative Complications
Vulvar Cancer
Procedure: assessment of therapy complications
Procedure: bioimpedance spectroscopy
Procedure: lymphadenectomy
Procedure: therapeutic conventional surgery
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of 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 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 ]

Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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

DISEASE CHARACTERISTICS:

  • Patients with vulvar cancer already enrolled onto GOG-0244 who will undergo 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 undergoing unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy and will receive multi-modality therapy (radiation +/- chemotherapy) after undergoing surgery are eligible
    • Patients may undergo sentinel node mapping as long as it is followed by a full lymphadenectomy during the same operative event
  • No patients with any prior clinical lower-extremity lymphedema

PATIENT CHARACTERISTICS:

  • Patients with a GOG performance status of 0, 1, or 2
  • Patients must have a serum albumin level of ≥ 3.0 g/dL within 14 days of entry
  • No patients who have a history of congestive heart failure, chronic renal disease, or chronic liver disease
  • No history of chronic lower-extremity swelling
  • No 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
  • No patients who are pregnant or currently breastfeeding
  • No patients with an allergic reaction to EKG electrodes

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No patients who have had prior lower-extremity vascular surgery (arterial or venous) or any inguinal, hip, knee, or ankle surgery, including orthopedic procedures
  • No patients who have had prior pelvic bilateral axillary or any pelvic, abdominal, inguinal, or lower-extremity radiation therapy
  • No patients who are going to receive another elective surgery during the same operative event as their inguinal lymphadenectomy and vulvar surgery
  • No patients with an implanted cardiac device such as a pacemaker or implantable cardioverter defibrillator
  • No patients who have been treated for, or are at risk of, bilateral arm lymphedema
  • No patients who have had bilateral auxiliary dissection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406769

Locations
United States, Missouri
Mercy-Springfield, Cancer Research Ctr. for the Ozarks Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W Carlson, DO         jay.carlson@mercy.net    
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Jay W. Carlson, DO Saint John's Physicians and Clinics
  More Information

Additional Information:
No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01406769     History of Changes
Other Study ID Numbers: CDR0000706551, GOG-0269
Study First Received: July 29, 2011
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board, Data Safety and Monitoring Board

Keywords provided by Gynecologic Oncology Group:
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

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

ClinicalTrials.gov processed this record on May 16, 2013