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LymphedemaPhase 2NCT01406769

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

A Phase 2 study testing Bioelectric Impedance Analysis, Lymphadenectomy and Therapeutic Conventional Surgery in people with Lymphedema and Perioperative/Postoperative Complications, run by Gynecologic Oncology Group at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bioelectric Impedance Analysis, Lymphadenectomy and Therapeutic Conventional Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
11 sitesUnited States
Study dates
16 Jul 2012to 10 Apr 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

Other trials in United States

About this study

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

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.

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
Bioelectric Impedance Analysis, Lymphadenectomy, Therapeutic Conventional Surgery
Medical subject headings
Lymphedema, Postoperative Complications, Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioelectric Impedance AnalysisProcedure or surgery

    Also called BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis

    Undergo preoperative and postoperative lower-extremity lymphedema assessment

  • LymphadenectomyProcedure or surgery

    Also called excision of the lymph node, Lymph Node Dissection, lymph node excision

    Undergo lymphadenectomy

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo radical vulvectomy or radical local excision

Study groups in NCT01406769
Study groupRoleWhat they receive
Diagnostic (bioimpedance to measure lymphedema)ExperimentalPatients 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.
Receives: Procedure: Bioelectric Impedance Analysis; Procedure: Lymphadenectomy; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 months post-operatively

  2. Frequency and severity of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2011 (estimated)
  2. Study start16 Jul 2012
  3. Primary completion10 Apr 2020
  4. Study completion10 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01406769
Sponsor's protocol ID
GOG-0269
Other IDs
NCI-2011-03798, CDR0000706551, GOG-0269, GOG-0269, GOG-0269, U10CA101165
Status last verified
May 2021
First submitted
29 Jul 2011
Last updated
7 May 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bioelectric Impedance Analysis, Lymphadenectomy and Therapeutic Conventional Surgery in people with Lymphedema and Perioperative/Postoperative Complications, run by Gynecologic Oncology Group at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements (limb volume and Stemmer Sign) (time frame: Up to 24 months post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01406769.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.

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