A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients With Metastatic Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 7
- 主要终点
- Change in body mass index/BMI from baseline to 4 months
研究概览
简要总结
The main purpose of this study is to see how pancrelipase affects the body mass index (BMI) in people with metastatic PDAC. BMI is a measure based on a person's height and weight. Other study goals are to explore two different dosing schedules of pancrelipase and to evaluate pancrelipase in people who do not have symptoms of EPI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Histopathologic or cytologic diagnosis of pancreatic adenocarcinoma, or adenosquamous cancer, or any non-neuroendocrine primary pancreas variant, including acinar cancer.
- •De novo or recurrent diagnosis of previously untreated stage IV PDAC with intent to receive FOLFIRINOX/mFOLFIRINOX.
- •No use of pancreatic enzyme replacement therapy within prior 2 weeks.
- •Patients with biliary obstruction are eligible provided biliary stenting has or will occur before treatment with FOLFIRINOX.
- •Ability to understand and the willingness to sign an informed consent document.
- •Ability to swallow capsules.
- •Age ≥18 years.
- •Anticipated life expectancy of at least 6 months.
排除标准
- •Chronic illness associated with malabsorption (celiac disease, cystic fibrosis, chronic pancreatitis, Crohn's disease).
- •Fibrosing colonopathy.
- •Prior history of surgical resection of the pancreas or gastric bypass.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pancrelipase.
- •Patients cannot receive radiation, IRE, or other localized therapy directed to the pancreas while on study.
研究组 & 干预措施
Arm 1
Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack
干预措施: Pertzye (Drug)
Arm 2
Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack
干预措施: Pertzye (Drug)
结局指标
主要结局
Change in body mass index/BMI from baseline to 4 months
时间窗: 4 months
The primary objective is a change in body mass index (BMI) 4 months from baseline while on pancreatic enzyme replacement therapy (PERT).
次要结局
未报告次要终点