L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- TNF-alpha
研究概览
简要总结
The study investigated the role of L-Carnitine supplementation on proinflammatory immune response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable pancreatic cancer, UICC Stage IV .
详细描述
Pancreatic cancer has the lowest 5-year survival rate of any cancer and ranks as the fourth leading cause of cancer death world wide. Several metabolic changes are present in the whole body in case of cancer so the investigators conducted a placebo controlled, double blinded, randomized, prospective and multicentre study to investigate, whether L-Carnitine supplementation may have an impact on malnutrition, cancer cachexia and cancer related fatigue in advanced pancreatic cancer.
Study drug: L-Carnitine 4g per day (vers) Placebo Study design: A multi-centre, double blind, and placebo-controlled, randomised, parallel group study
Patient population: Patients with advanced pancreatic carcinoma Number of patients: Total of 90 patients in two equal groups number of centres: 4 (Greifswald, Magdeburg, Berlin,Heidelberg,all Germany) Duration of dosing: 12 weeks
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced pancreatic cancer (UICC Stage IV)
- •Karnofsky Index larger than 60
- •compliance
- •consent to participate to the study
排除标准
- •Child-Pugh classification of liver failure greater than Child B,
- •a known second malignant tumor
- •oral or parenteral supplementation with omega-3-fatty acids
- •treatment with thalidomide or Infliximab
- •mental or physical disorders
结局指标
主要结局
TNF-alpha
时间窗: 12 weeks
Influence of L-Carnitine on proinflammatory cytokine TNF-alpha
次要结局
- nutritional status(12 weeks)
- Quality of life(12 weeks)
- survival(1 year)
- hospital stay(1 year)