Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Questionnaire EORTC - Quality of Life
研究概览
简要总结
A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).
详细描述
Pancreatic cancer is an extremely aggressive malignancy characterized by extensive invasion, early metastasis, and marked cachexia. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia and deterioration in performance status, even when their tumour burden is low. Therefore, one of the most important therapeutic targets is the improvement of quality of life. Supplementation with parenteral nutrition improves Quality of Life in subjects with advanced cancer cachexia. The European Society of Parenteral and Enteral Nutrition recommend PN only for malnourished subjects but does not reflect situation in cancer cachexia patients At present, no 2nd-line therapy (or higher) is recommended for pancreatic adenocarcinoma, but often asked for.
Within this clinical trial, we evaluate if parenteral nutrition in combination with chemotherapy in subjects with advanced pancreatic adenocarcinoma have an impact on quality of life?
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
- 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
- •Written informed consent
- •Histological confirmed advanced pancreatic adenocarcinoma
- •At least one previous chemotherapy (gemcitabine-based)
- •≥ 18 years old
- •Body weight ≥ 50 and ≤ 95 kg
- •Negative pregnancy test (females of childbearing potential)
- •Willingness to perform double-barrier contraception during study
- •Expected life expectancy > 3 months
排除标准
- •Major surgery < 4 weeks prior to enrollment
- •Weight loss > 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days
- •PINI-Index > 10
- •Pregnancy or breastfeeding
- •> 4 weeks of parenteral nutrition within the last 6 months
- •Parenteral nutrition < 4 weeks prior to enrollment
- •Vulnerable populations (e.g. subjects incapable of giving consent personally)
- •Subject selection conflicts with warnings, precautions and contraindications stated for any investigational product
研究组 & 干预措施
PN, Chemotherapy, Nutritional Care
5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43.
Patients receive also Best Supportive Nutritional Care defined as nutritional consultation and recommendation by experienced ecotrophologists.
Intervention: Supportive Parenteral Nutrition
干预措施: SMOF Kabiven (Drug)
结局指标
主要结局
Questionnaire EORTC - Quality of Life
时间窗: every 1st and 22nd day of a cycle
The following questionnaires will be given to subjects: * EORTC QLQ-C30 (every 1st and 22nd day of a cycle) * EORTC QLQ Pan-26 (every 1st and 22nd day of a cycle)
次要结局
- Assessment of nutritional status(every 1st and 22nd day of a cycle))