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A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of Vulvar Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Lymphedema, Perioperative/Postoperative Complications, Vulvar Cancer

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Trial Information

A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of Vulvar Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity, specificity, and feasibility of bioimpedance technology compared to current techniques in measuring lower-extremity lymphedema in patients undergoing surgery for vulvar cancer

Safety Issue:

No

Principal Investigator

Jay W. Carlson, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Saint John's Physicians and Clinics

Authority:

United States: Institutional Review Board, Data Safety and Monitoring Board

Study ID:

CDR0000706551

NCT ID:

NCT01406769

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Lymphedema
  • Perioperative/Postoperative Complications
  • Vulvar Cancer
  • 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
  • Lymphedema
  • Postoperative Complications
  • Vulvar Neoplasms

Name

Location

Mercy-Springfield, Cancer Research Ctr. for the OzarksSpringfield, Missouri  65804