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

This study has been terminated.
(Slow Accruals)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences Identifier:
First received: December 10, 2013
Last updated: January 17, 2017
Last verified: September 2016
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.

Condition Intervention
Extensive Stage Small Cell Lung Cancer
Procedure: bioelectric impedance analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 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.

  • Standardized phase angle measure [ Time Frame: 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.

Secondary Outcome Measures:
  • Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 2 years ]
    Logistic regression will be used to analyze the association between standardized phase angle and best overall response.

  • Overall survival [ Time Frame: 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.

  • Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 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.

Enrollment: 1
Study Start Date: February 2014
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:


I. To evaluate the association between phase angle (PA) measurement and progression-free survival (PFS).


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.


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT02011087

United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Principal Investigator: Jimmy Ruiz Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences Identifier: NCT02011087     History of Changes
Other Study ID Numbers: CCCWFU 99813A  NCI-2013-02339  CCCWFU 99813A  P30CA012197 
Study First Received: December 10, 2013
Last Updated: January 17, 2017

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on January 23, 2017