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

Extensive Stage Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02011087
• Other study ID #: IRB00025808
• Secondary ID: NCI-2013-02339CC
• Status: Terminated
• Phase: N/A
• Start date: February 2014
• Est. completion date: September 2016

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Procedure:
• bioelectric impedance analysis
Undergo bioelectric impedance analysis

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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