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

Wake Forest University (WFU)

Status: Terminated

Conditions: Extensive Stage Small Cell Lung Cancer

Treatments: Procedure: bioelectric impedance analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02011087

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU 99813A (Other Identifier)

IRB00025808

NCI-2013-02339 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Diagnostic (bioelectric impedance analysis)

Experimental group

Description:

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

Treatment:

Procedure: bioelectric impedance analysis