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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

Primary Purpose

Lymphedema, Perioperative/Postoperative Complications, Stage IA Vulvar Cancer AJCC v7

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bioelectric Impedance Analysis
Lymphadenectomy
Therapeutic Conventional Surgery
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences
  • Indiana University/Melvin and Bren Simon Cancer Center
  • Saint Vincent Hospital and Health Care Center
  • University of Minnesota/Masonic Cancer Center
  • Mercy Hospital Springfield
  • Women's Cancer Center of Nevada
  • Ohio State University Comprehensive Cancer Center
  • University of Oklahoma Health Sciences Center
  • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • M D Anderson Cancer Center
  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (bioimpedance to measure lymphedema)

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 29, 2011
Last Updated
May 4, 2021
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01406769
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 16, 2012 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
April 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Perioperative/Postoperative Complications, Stage IA Vulvar Cancer AJCC v7, Stage IB Vulvar Cancer AJCC v7, Stage II Vulvar Cancer AJCC v7, Stage IIIA Vulvar Cancer AJCC v7, Stage IIIB Vulvar Cancer AJCC v7, Stage IIIC Vulvar Cancer AJCC v7, Stage IVA Vulvar Cancer AJCC v7, Stage IVB Vulvar Cancer AJCC v6 and v7

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (bioimpedance to measure lymphedema)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Bioelectric Impedance Analysis
Other Intervention Name(s)
BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis, Bioimpedance Analysis
Intervention Description
Undergo preoperative and postoperative lower-extremity lymphedema assessment
Intervention Type
Procedure
Intervention Name(s)
Lymphadenectomy
Other Intervention Name(s)
excision of the lymph node, Lymph Node Dissection, lymph node excision
Intervention Description
Undergo lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo radical vulvectomy or radical local excision
Primary Outcome Measure Information:
Title
Sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements (limb volume and Stemmer Sign)
Description
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.
Time Frame
Up to 24 months post-operatively
Title
Frequency and severity of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time Frame
Up to 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay W Carlson
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Indiana University/Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Saint Vincent Hospital and Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Women's Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute-Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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