Lung Cancer Clinical Trial
Bioelectrical Impedance Phase Angle in Predicting Treatment Outcome in Patients With Extensive Stage Small Cell Lung Cancer Receiving First-Line Chemotherapy
Summary
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.
Full 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 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
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There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States
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