Pancreatic Enzyme Replacement Therapy (PERT) for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?
详细描述
Randomized, double-blind clinical trial aiming to assess the impact of pancreas enzyme replacement therapy in weight loss and quality of life.
Prevalence of pancreatic exocrine insufficiency (PEI) will be determined with fecal elastase-1 test (FE1) in patients with unresectable pancreatic cancer, without evidence of pancreatic duct (PD) or common bile duct (CBD) obstruction based on MRI or / and endoscopic ultrasound (EUS).
Patients with PEI (FE1 <200) receive Pertzye or placebo in a cross-over fashion, each for 4 weeks.
Body weight, body mass index (BMI), body composition (Bioimpedance), are measured at the time of diagnosis of PEI and at 4 and 10 weeks of cross-over treatment. Baseline measurement of Vitamin D-25, Vitamin A, iron (ferritin, total iron binding capacity (TIBC), iron), Vitamin B12,Tissue transglutaminase IgA (tTG) with total Immunoglobulin A (IgA).
Quality of Life (pain, diarrhea, weight, bloating, etc.) assessed at 0,4,10 weeks with the Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer (FACT-Hep) for physical, social, emotional, and functional quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-80 years
- •Underlying pancreatic adenocarcinoma, unresectable (local invasion or distant metastasis)
- •On established chemotherapy regimen for pancreas cancer, which will be continued over the time of study
- •Fecal elastase-1 test (FE1) less than 200 mcg pancreatic elastase/g stool
排除标准
- •Common bile duct obstruction resulting in obstructive jaundice
- •Celiac disease
- •Crohn's disease
- •Benign pancreatic conditions
- •Bowel obstruction
- •Surgically altered bowel anatomy
研究组 & 干预措施
Placebo First, then Pancrelipase
Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).
干预措施: Pancrelipase (Drug)
Placebo First, then Pancrelipase
Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).
干预措施: Placebo Oral Capsule (Drug)
Pancrelipase First, then Placebo
Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).
干预措施: Pancrelipase (Drug)
Pancrelipase First, then Placebo
Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Change in Body Weight
时间窗: Baseline, 4 weeks, 10 weeks
Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.
次要结局
- Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks(Baseline, 10 weeks)
- Change in Body Weight Composition(Baseline, 4 weeks, 10 weeks)
- Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks(Baseline, 4 weeks)
研究者
Massimo Raimondo, M.D.
Professor, College of Medicine
Mayo Clinic