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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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 |
- 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) |
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 |
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| 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 | |
| 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:
|
Lymphedema Postoperative Complications Vulvar Neoplasms Lymphatic Diseases Pathologic Processes Genital Neoplasms, Female |
Urogenital Neoplasms Neoplasms by Site Neoplasms Vulvar Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 22, 2013