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

Primary Purpose

Extensive Stage Small Cell Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bioelectric impedance analysis
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Comprehensive Cancer Center of Wake Forest University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (bioelectric impedance analysis)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Overall survival
A Cox proportional hazards model will be used.
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.

Full Information

First Posted
December 10, 2013
Last Updated
July 3, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02011087
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow Accruals
Study Start Date
February 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Stage Small Cell Lung Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (bioelectric impedance analysis)
Arm Type
Experimental
Arm Description
Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.
Intervention Type
Procedure
Intervention Name(s)
bioelectric impedance analysis
Other Intervention Name(s)
BIA, bioelectric impedance, bioelectric impedance test, bioimpedance analysis
Intervention Description
Undergo bioelectric impedance analysis
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Analyzed using Kaplan-Meier plots and a log-rank test to test the difference in progression-free survival and high/low phase angle measures.
Time Frame
From the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years
Title
Standardized phase angle measure
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST)
Description
Logistic regression will be used to analyze the association between standardized phase angle and best overall response.
Time Frame
Up to 2 years
Title
Overall survival
Description
A Cox proportional hazards model will be used.
Time Frame
From the start of treatment to date of death or date of last contact, assessed up to 2 years
Title
Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Description
For those events that are the most common, the mean standardized phase angle for those experiencing the condition will be presented.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmy Ruiz
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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