Extensive Stage Small Cell Lung CancerNCT02011087
Bioelectrical Impedance Phase Angle in Predicting Treatment Outcome in Patients With Extensive Stage Small Cell Lung Cancer Receiving First-Line Chemotherapy
A study testing bioelectric impedance analysis in people with Extensive Stage Small Cell Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- bioelectric impedance analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Small Cell Lung Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the association between phase angle (PA) measurement and progression-free survival (PFS).
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- bioelectric impedance analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioelectric impedance analysisProcedure or surgery
Also called BIA, bioelectric impedance, bioelectric impedance test, bioimpedance analysis
Undergo bioelectric impedance analysis
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (bioelectric impedance analysis) | Experimental | Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Receives: Procedure: bioelectric impedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Up to 2 years
Overall survival
A Cox proportional hazards model will be used.
Measured: 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
For those events that are the most common, the mean standardized phase angle for those experiencing the condition will be presented.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Slow Accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jimmy Ruiz, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011087
- Sponsor's protocol ID
- IRB00025808
- Other IDs
- NCI-2013-02339, CCCWFU 99813A, P30CA012197
- Status last verified
- Jul 2018
- First submitted
- 10 Dec 2013
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02011087
- Acronym / sponsor ID
- IRB00025808
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accruals
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the association between phase angle (PA) measurement and progression-free survival (PFS).
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (bioelectric impedance analysis) | Experimental | Procedure: bioelectric impedance analysisPatients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioelectric impedance analysisAlso: BIA, bioelectric impedance, bioelectric impedance test, bioimpedance analysisUndergo bioelectric impedance analysis | Procedure or surgery | Diagnostic (bioelectric impedance analysis) |
Primary outcome
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.
3 secondary outcomes
Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 2 years
Overall survival
Time frame: 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
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Slow Accruals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimmy Ruiz principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioelectric impedance analysis in people with Extensive Stage Small Cell Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow Accruals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.