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

Not Applicable

Terminated

• Conditions: Extensive Stage Small Cell Lung Cancer
• Interventions: Procedure: bioelectric impedance analysis

• Registration Number: NCT02011087
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Study Start: 2014-02
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (bioelectric impedance analysis)	bioelectric impedance analysis	Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.

Primary Outcome Measures

Name	Time	Method
Standardized phase angle measure	Baseline	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.
Progression-free survival	From the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years	Analyzed using Kaplan-Meier plots and a log-rank test to test the difference in progression-free survival and high/low phase angle measures.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0	Up to 2 years	For those events that are the most common, the mean standardized phase angle for those experiencing the condition will be presented.
Overall survival	From the start of treatment to date of death or date of last contact, assessed up to 2 years	A Cox proportional hazards model will be used.
Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST)	Up to 2 years	Logistic regression will be used to analyze the association between standardized phase angle and best overall response.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States