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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1
Undergo bioelectric impedance analysis
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
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.
Time frame: 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.
Time frame: Baseline
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.
Time frame: Up to 2 years
Overall survival
A Cox proportional hazards model will be used.
Time frame: 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.
Time frame: Up to 2 years
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