Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Standardized phase angle measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Diagnostic (bioelectric impedance analysis)
Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.
干预措施: bioelectric impedance analysis (Procedure)
结局指标
主要结局
Standardized phase angle measure
时间窗: 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.
Progression-free survival
时间窗: 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.
次要结局
- Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0(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)
- Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST)(Up to 2 years)