Pilot Project for Cardiopulmonary and Functional Evaluation in Patients With Pancreatic Cancer Associated Cachexia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The number of patients who have changes in echocardiography, pulmonary function or one or more part of their functional evaluation tests
研究概览
简要总结
Cachexia is a systemic catabolic syndrome with apparent effect on skeletal muscles, tolerance to chemotherapy, early toxicity and quality of life; however, its effect on cardiopulmonary function is not well understood. Preclinical studies demonstrated diaphragmatic muscle wasting(29) and left ventricular wasting and fibrosis associated with mouse cachexia models.(40) Many patients, who experience cancer cachexia, describe a generalized debility and a sense of breathlessness(41) despite adequate oxygenation in the peripheral blood as measured by pulse oximetry. Whether this is related to deconditioning associated with chemotherapy or related to direct effect on cardiac and diaphragmatic muscles remains unknown. In this pilot study, the investigators propose to perform a preliminary evaluation of the cardiopulmonary function in patients with pancreatic cancer, who are likely to develop cachexia, to assess for the feasibility of performing a larger prospective study to understand the impact of cancer cachexia on cardiopulmonary function. This pilot study will provide the foundation to potentially identify cachexia in early stages (pre-cachexia) to develop pharmacological or exercise based interventions to prevent or delay its progression. Based on clinical experience and published literature, it is expected that 60-70% of patients will have >10% weight loss during the course of this disease. More commonly, this is associated with clinical or radiographic disease progression, but certainly it can happen throughout the course of the disease even without disease progression.
详细描述
Primary Objective:
To assess the feasibility of performing a prospective cardiopulmonary and physical function assessment in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who are expected to develop cachexia.
Secondary Objectives:
- To measure the changes in maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) in patients with progressive PDAC and/or cancer associated cachexia
- To measure changes in strain echocardiography in patients with progressive PDAC and/or cancer associated cachexia
- To assess functional changes in patients with progressive PDAC and/or cancer associated cachexia
- To assess body composition changes associated with cachexia or disease progression
- To measure the levels of cytokines from peripheral blood in patients with cachexia
Procedures:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with locally advanced, metastatic or recurrent pancreatic ductal adenocarcinoma (PDAC)
- •Patients who are being treated and/or followed at Indiana University Simon Cancer Center or Eskenazi Hospital
- •ECOG PS 0-2 at the time of study enrollment
- •Life expectancy > 6 months
- •Adequate organ function
- •As defined by the following laboratory values at study entry:
- •Hemoglobin ≥ 9 g/dL (transfusions are acceptable)
- •ANC ≥ 1.5 x 109/L
- •Platelets ≥ 100 x 109/L
- •Creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
- •Total bilirubin ≤ 1.5 x ULN
- •AST/ALT ≤ 3 x ULN
- •Willingness to sign informed consent and to perform pulmonary function tests (PFTs) and strain echocardiogram
排除标准
- •Known history of congestive heart failure (NYHA class III or IV)
- •Reported weight loss more than 10% within 3 months prior to study entry
- •Known history of pulmonary disease such as pulmonary hypertension, chronic obstructive pulmonary disease requiring medical management or previous lung resection
- •Current liver cirrhosis
- •Current chronic kidney disease
- •Inability or refusal to receive systemic therapy
- •Inability to comply with pulmonary function tests (PFTs)
- •Large volume ascites interfering with ability of respiration
- •Current unstable angina (or history of within last 6 months)
- •Recent myocardial infraction (within last 6 months)
- •Recent pneumothorax (within last 6 months)
- •Uncontrolled hypertension (per investigator's discretion)
- •Lung biopsy within one week from PFT
- •Recent surgery < 4 weeks
结局指标
主要结局
The number of patients who have changes in echocardiography, pulmonary function or one or more part of their functional evaluation tests
时间窗: Baseline to disease progression or development of cachexia (approximately 6 months)
Changes are significant if they are \> 15% from baseline. Development of cachexia is defined by ≥ 10% of weight loss from baseline.
次要结局
- Change in self-reported quality of life(Baseline to disease progression or development of cachexia (approximately 6 months))
- Change in strain echocardiogram(Baseline to disease progression or development of cachexia (approximately 6 months))
- Change in functional evaluation test(Baseline to disease progression or development of cachexia (approximately 6 months))
- Change in pulmonary function(Baseline to disease progression or development of cachexia (approximately 6 months))
- Change in self-reported function via PG-SGA questionnaire(Baseline to disease progression or development of cachexia (approximately 6 months))
- Change in self-reported function via LEFS questionnaire(Baseline to disease progression or development of cachexia (approximately 6 months))
- Change in levels of cytokines(Baseline to disease progression or development of cachexia (approximately 6 months))
- Change in body composition via CT scan(Baseline to disease progression or development of cachexia (approximately 6 months))
研究者
Safi Shahda
Assistant Professor of Clinical Medicine
Indiana University