NCT02011087

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

2.6 years

First QC Date

December 10, 2013

Last Update Submit

July 3, 2018

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST)

    Up to 2 years

  • Overall survival

    From the start of treatment to date of death or date of last contact, assessed up to 2 years

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

    Up to 2 years

Study Arms (1)

Diagnostic (bioelectric impedance analysis)

EXPERIMENTAL

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

Procedure: bioelectric impedance analysis

Interventions

bioelectric impedance analysisPROCEDURE

Undergo bioelectric impedance analysis

Also known as: BIA, bioelectric impedance, bioelectric impedance test, bioimpedance analysis
Diagnostic (bioelectric impedance analysis)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

  • Jimmy Ruiz

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 13, 2013

Study Start

February 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 5, 2018

Record last verified: 2018-07

Locations

US(1)