We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioelectrical Impedance Phase Angle in Predicting Treatment Outcome in Patients With Extensive Stage Small Cell Lung Cancer Receiving First-Line Chemotherapy

This study has been terminated.
(Slow Accruals)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02011087
First Posted: December 13, 2013
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
This clinical trial studies bioelectrical impedance phase angle in predicting treatment outcome in patients with extensive stage small cell lung cancer receiving first-line chemotherapy. Diagnostic procedures, such as bioelectrical impedance analysis, may help predict a patient's response to treatment for small cell lung cancer.

Condition Intervention
Extensive Stage Small Cell Lung Cancer Procedure: bioelectric impedance analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: From the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years ]
    Analyzed using Kaplan-Meier plots and a log-rank test to test the difference in progression-free survival and high/low phase angle measures.

  • Standardized phase angle measure [ Time Frame: Baseline ]
    A Cox proportional hazards model will be used. The standardized phase angle measure will be treated as a continuous measure and baseline characteristics will be included as covariates in the survival model.


Secondary Outcome Measures:
  • Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 2 years ]
    Logistic regression will be used to analyze the association between standardized phase angle and best overall response.

  • Overall survival [ Time Frame: From the start of treatment to date of death or date of last contact, assessed up to 2 years ]
    A Cox proportional hazards model will be used.

  • Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ]
    For those events that are the most common, the mean standardized phase angle for those experiencing the condition will be presented.


Enrollment: 1
Actual Study Start Date: February 2014
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (bioelectric impedance analysis)
Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.
Procedure: bioelectric impedance analysis
Undergo bioelectric impedance analysis
Other Names:
  • BIA
  • bioelectric impedance
  • bioelectric impedance test
  • bioimpedance analysis

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the association between phase angle (PA) measurement and progression-free survival (PFS).

SECONDARY OBJECTIVES:

I. To evaluate the association between PA measurement and treatment-related outcomes of treatment response, adverse treatment events, and overall survival (OS).

II. To determine the feasibility of obtaining PA measurements at a single time point in patients undergoing evaluation in thoracic oncology clinics.

OUTLINE:

Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.

After completion of study treatment, patients are followed up every 2-3 months for two years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A primary histopathological and/or cytopathological diagnosis of small cell lung cancer (SCLC)
  • Diagnosis of extensive stage disease (extensive stage [ES]-SCLC), with stage established by computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) scan
  • Scheduled to receive front-line platinum-based chemotherapy with carboplatin or cisplatin plus etoposide
  • Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document

Exclusion Criteria:

  • No recent chemotherapy or surgery, as defined as in the last 6 months
  • Presence of a pacemaker or defibrillator
  • Patients with major chronic disease known to adversely affect PA, including human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), congestive heart failure, tuberculosis
  • Patients with body mass index (BMI) greater than 34 or less than 16
  • Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
  • Unable or unwilling to follow protocol requirements
  • Pregnant women are excluded from participation due to inability to participate in required chemotherapy regimen
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011087


Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jimmy Ruiz Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02011087     History of Changes
Other Study ID Numbers: CCCWFU 99813A
NCI-2013-02339 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 99813A ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Submitted: December 10, 2013
First Posted: December 13, 2013
Last Update Posted: August 1, 2017
Last Verified: September 2016

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms