Prevention of Malnutrition Through Oral Nutritional Supplements in Cancer Patients Receiving Palliative Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Change in disease-related quality of life
研究概览
简要总结
The aim of the randomized controlled study is to determine effects of an adjusted amount of oral nutritional supplements on the quality of life, the nutritional status, side effects, and response to therapy, in patients with pancreatic and hepatocellular carcinoma receiving palliative therapy.
详细描述
Cancer is often associated with malnutrition and weight loss. The occurence of malnutrition during the course of the disease depends on the type, extent, and therapy of the tumor. Pancreatic cancer patients and patients with hepatocellular carcinoma are particularly at risk of developing a pronounced weight loss. Cancer-related malnutrition has negative impact on the response to therapy, survival, quality of life, and the infection rate of patients, resulting in prolonged hospital stays and higher costs for health care. Maintaining or optimizing the quality of life in patients receiving palliative therapy has priority. Since a poor nutritional status affects the quality of life, patients might benefit from the use of an adjusted amount of oral nutritional supplements.
To determine the effects of oral nutritional supplements, a controlled randomized study will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •assured diagnosis of pancreatic cancer/hepatocellular carcinoma, not treatable with curative intent
- •palliative systemic therapy of pancreatic cancer respectively palliative therapy of hepatocellular carcinoma with Sorafenib or TACE (transarterial chemoembolization)
- •written informed consent prior to inclusion
排除标准
- •prefinal phase with an estimated life expectancy of less than three months
- •nutritional support through tube feeding or a central venous catheter
- •serious malassimilation (assessed by anamnesis)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 2
- •hepatic encephalopathy ≥ degree 2
结局指标
主要结局
Change in disease-related quality of life
时间窗: Every four weeks for a period of three months and after six months
Disease-related quality of life is assessed by using the standardized questionnaire "Functional Assessment of Cancer Therapy - Hepatobiliary questionaire" (FACT-Hep).
Change in health-related quality of life
时间窗: Every four weeks for a period of three months and after six months
Health-related quality of life is assessed by using the standardized questionnaire "Short Form-36 Health Survey" (SF36).
次要结局
- Body mass index (BMI)(Every four weeks for a period of three months and after six months)
- Body composition(Every four weeks for a period of three months and after six months)
- Grip strength [lb](Every four weeks for a period of three months and after six months)
- Score (points) of nutritional risk screening(Every four weeks for a period of three months and after six months)
- Laboratory parameters(Every four weeks for a period of three months and after six months)