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

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.

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