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

Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Small Cell Lung Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Extensive Stage Small Cell Lung Cancer
• Intervention / Treatment: Procedure: bioelectric impedance analysis

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (bioelectric impedance analysis); Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.	Procedure: bioelectric impedance analysis; Undergo bioelectric impedance analysis; Other Names: BIA; bioelectric impedance; bioelectric impedance test; bioimpedance analysis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jimmy Ruiz, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: IRB00025808; P30CA012197 (U.S. NIH Grant/Contract); NCI-2013-02339 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 99813A (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No