Clinical trial NCT02011087: Bioelectrical Impedance Phase Angle in Predicting Treatment Outcome in Patients With Extensive Stage Small Cell Lung Cancer Receiving First-Line Chemotherapy
Official title: Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Extensive Stage Small Cell Lung Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-12-13
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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

Primary outcomes:
measure: Progression-free survival
timeFrame: From the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years
measure: Standardized phase angle measure
timeFrame: Baseline
Secondary outcomes:
measure: Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Up to 2 years
measure: Overall survival
timeFrame: From the start of treatment to date of death or date of last contact, assessed up to 2 years
measure: Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jimmy Ruiz
role: PRINCIPAL_INVESTIGATOR
References: