Preoperative Nutritional Supplementation With Immunomodulators for Patients With Resectable Pancreatic Adenocarcinoma: Efficacy and Optimal Dose
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in levels of circulating Myeloid derived suppressor cells
研究概览
简要总结
The purpose of this study is to determine the optimal effective dose for preoperative nutritional supplementation with immunomodulators on immune function and perioperative outcomes following pancreaticoduodenectomy for pancreatic adenocarcinoma.
详细描述
Study Objectives: The primary objective of this study is to determine the optimal effective dose for preoperative nutritional supplementation with immunomodulators on immune function and perioperative outcomes following pancreaticoduodenectomy for pancreatic adenocarcinoma.
Primary Endpoints:
The primary endpoints will be effect on immunological profile (circulating Myeloid derived suppressor cells, circulating B cells, NK cells, CD4 and CD8 cells), serum arginine levels, immunological milieu of the tumor (tumor infiltrating lymphocytes), overall morbidity rate and infectious complication rates.
Secondary Endpoints:
- Monitor Safety and Tolerability
- Hospital Length of Stay
- Readmission rate
- One-year event free survival
- Effect on nutritional parameters (serum total protein, prealbumin, albumin and transferrin)
- Effect on acute phase reactants (CRP, IL6, TNF alpha)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Over 18 years of age, of any race or sex, with histologic and/or radiologic proof of pancreatic adenocarcinoma (PDAC)
- •PDAC that is deemed resectable by the operating surgeon
- •Non-pregnant with an acceptable contraception method in premenopausal women
- •Signed, written informed consent
排除标准
- •Active bacterial, viral or fungal infection within 21 days of study entry
- •Women who are pregnant or breast feeding
- •Evidence of metastatic disease
- •Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous cell carcinoma of the skin
- •Inability to take oral or nasojejunal nutritional supplements
- •Patients with immunodeficiency conditions
- •Patients on chronic steroid therapy
- •Patients with know sensitivity to arginine, omega-3 fatty acids or glutamine
结局指标
主要结局
Change in levels of circulating Myeloid derived suppressor cells
时间窗: Within 2 weeks of study intervention (at pre-anesthesia visit) to surgery. Study intervention to start 5 days before surgery
The variable that will be compared in this analysis will be • Change in circulating Myeloid derived suppressor cells before and after intervention (before intervention: within 2 weeks before surgery; after intervention: day of surgery)
Overall morbidity rate.
时间窗: 30 day morbidity from surgery
The variables that will be compared in this analysis will be • overall morbidity rate (adverse effects): number of patients with adverse effects and total number of adverse effects as assessed by CTCAE v4.0 (which includes number of patients with serious adverse effects: Grade 3 or higher, CTCAE v4.0 and number of patients with infectious complication rates)
次要结局
- Change in serum arginine levels(Within 2 weeks of study intervention (at pre-anesthesia visit) to surgery. Study intervention to start 5 days before surgery)
- Hospital length of stay(90 days from surgery)
- Tolerability of Supplement(90 days from surgery)
研究者
Prejesh Philips
Assistant Professor
University of Louisville