Open label randomized, multicentre, controlled trial of pancreatic enzyme replacement therapy (PERT) for pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- The primary endpoint is defined as the change in body weight (kg and percentage) from baseline to the end of the controlled phase, 3 months from inclusion, as well as to the end of the study, 6 months from inclusion, in the two groups of patients.
研究概览
简要总结
As hypothesis, PERT in patients with unresectable pancreatic cancer is associated with weight gain and improved nutritional status, which, in turn, improves the performance status of patients, quality of life and tolerance to chemotherapy. This approach could have therefore a benefit on survival. To test this hypothesis, the primary objective of the study is to evaluate the impact of PERT on body weight in patients with unresectable pancreatic cancer.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years, any gender, fulfilling all the following criteria will be considered for enrolment into the study
- •Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer.
- •Tumour located in the head of the pancreas
- •Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS)
- •Significant weight loss (≥5% of the usual body weight, over the last 6 months) at screening
- •Life expectancy of at least six months at screening
- •Signed informed consent to the study
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
排除标准
- •Hypersensitivity to pancreatin of porcine origin or to any of the excipients
- •Unwillingness to participate in the study
- •Patients with body weight <46 kg
- •Patients with pancreatitis in the acute phase.
- •Patients with contraindications to PPI concomitant treatment.
- •Inability to comply with the study visits and study protocol, whatever the reason
- •Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned
- •Patients already on PERT
- •Prior history of upper gastrointestinal or pancreatic surgery
- •Short life expectancy (shorter than 6 months)
- •Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy)
- •Patients in whom a pancreatic stent has been placed
- •Unsolved gastric outlet obstruction
结局指标
主要结局
The primary endpoint is defined as the change in body weight (kg and percentage) from baseline to the end of the controlled phase, 3 months from inclusion, as well as to the end of the study, 6 months from inclusion, in the two groups of patients.
The primary endpoint is defined as the change in body weight (kg and percentage) from baseline to the end of the controlled phase, 3 months from inclusion, as well as to the end of the study, 6 months from inclusion, in the two groups of patients.
次要结局
- Change in haemoglobin, lymphocytes, serum concentration of nutritional markers (albumin, prealbumin, retinol binding protein, transferrin, fat-soluble vitamins, total and HDL cholesterol, triglycerides, cholinesterase, magnesium, selenium, and zinc), HbA1C and C-reactive protein (CRP) from baseline to the end of the controlled phase (3 months) and the end of the study (6 months) in the two groups of patients
- Change in Karnofsky performance status from baseline to the end of the controlled phase and the end of the study in the two groups of patients
- Change in malabsorption-related symptoms (diarrhoea, flatulence, abdominal distention, meteorism, abdominal cramps) and Patient-Generated Subjective Global Assessment (PG-SGA) from baseline to the end of the controlled phase and the end of the study in the two groups of patients
- Change in quality of life (EORTC QLQ-PAN26) from baseline to the end of the controlled phase and the end of the study in the two groups of patients
- Tolerance to chemotherapy defined as the percentage of the optimal dose of chemotherapeutic agents administered at months 3 and 6 from inclusion
- Survival over 3 and 6 months from inclusion
研究者
Juan Enrique Domínguez-Muñoz
Scientific
Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela