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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Small Cell Lung Cancer

Conditions
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Extensive Stage Small Cell Lung Cancer

Intervention / Treatment
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* Procedure: bioelectric impedance analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (bioelectric impedance analysis)<br>Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. | Procedure: bioelectric impedance analysis<br>* Undergo bioelectric impedance analysis<br>* Other names: bioimpedance analysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Analyzed using Kaplan-Meier plots and a log-rank test to test the difference in progression-free survival and high/low phase angle measures. | From the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years | 
| Standardized phase angle measure | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST) | Logistic regression will be used to analyze the association between standardized phase angle and best overall response. | Up to 2 years | 
| Overall survival | A Cox proportional hazards model will be used. | From the start of treatment to date of death or date of last contact, assessed up to 2 years | 
| Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | For those events that are the most common, the mean standardized phase angle for those experiencing the condition will be presented. | Up to 2 years |