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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02011087
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 31
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Extensive Stage Small Cell Lung Cancer	Procedure: bioelectric impedance analysis	N/A

Detailed Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

1. To evaluate the association between PA measurement and treatment-related outcomes of treatment response, adverse treatment events, and overall survival (OS).

2. 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 Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Small Cell Lung Cancer
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Progression-free survival [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.

2. Standardized phase angle measure [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

1. Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST) [Up to 2 years]

   Logistic regression will be used to analyze the association between standardized phase angle and best overall response.

2. Overall survival [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.

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

• Principal Investigator: Jimmy Ruiz, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02011087
• Other Study ID Numbers: IRB00025808; NCI-2013-02339; CCCWFU 99813A; P30CA012197
• First Posted: Dec 13, 2013
• Last Update Posted: Jul 5, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma

Study Results

No Results Posted as of Jul 5, 2018