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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT02011087
First received: December 10, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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: Endpoint Classification: Efficacy Study
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 Comprehensive Cancer Center of Wake Forest University:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    For those events that are the most common, the mean standardized phase angle for those experiencing the condition will be presented.


Estimated Enrollment: 50
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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011087

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Jimmy Ruiz    336-716-4464    jruiz@wakehealth.edu   
Principal Investigator: Jimmy Ruiz         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Jimmy Ruiz Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov 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: July 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014