Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors
试验速览
- 阶段
- 不适用
- 入组人数
- 298
- 主要终点
- Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1.
研究概览
简要总结
Recent pre-clinical data provide strong evidence that short-term starvation before the administration of cytostatic drugs for the chemotherapy of solid tumors leads to significantly higher efficacy and lower toxicity levels. However, these findings have so far not been validated in patients. The aim of this trial is to provide first clinical evidence regarding the impact of pre-chemotherapeutic short-term starvation on response to therapy (primary endpoint). Additionally, progression-free survival, adverse events, and overall survival will be monitored (secondary endpoints). In perspective, short-term starvation before chemotherapy could represent a simple and secure way to improve both efficacy and tolerance of chemotherapies at low cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patient (male/female) ≥ 18 years of age
- •Written informed consent obtained prior to any trial specific procedure
- •Patient suffering from gastrointestinal tumors: Cholangiocarcinoma (CC), Pancreatic ductal adenocarcinoma (PDAC), Colorectal Cancer (CRC), Gastric Cancer (GC)/ Adenocarcinoma of the Esophagogastreal Junction (AEG) / Esophagus cancer (EC).
- •Planned to receive palliative chemotherapy
- •No prior palliative chemotherapy
- •ECOG performance status of 0 or 1
- •Life expectancy of 12 weeks or more
- •Adequate hematological parameters, as demonstrated by:
- •Hemoglobin > 9.0 g/dl (5.6 mmol/l)
- •WBC ≥ 3.0 x 109/l
- •ANC ≥ 1500/mm³
- •Platelets ≥ 75 x 109/l
- •S-creatinine ≤ 1.5 mg/dl (132 µmol/l)
排除标准
- •Underweight (BMI < 18.5)
- •Insulin-dependent diabetes mellitus
- •Renal failure requiring hemo- or peritoneal dialysis
- •Pregnant or breast-feeding women
- •Drug/alcohol abuse
结局指标
主要结局
Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1.
时间窗: Three Months
Primary endpoint of this study is to assess the improvement in response to therapy for patients undergoing short-term starvation before chemotherapy of solid tumors in comparison to patients without dietary restrictions. Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1.
次要结局
未报告次要终点
研究者
Dr. Michael Hötker
Dr. med.
University Hospital Tuebingen