NCT02745197撤回2 期
Factors That Regulate Components of a Nutritional Supplement to Support Skeletal Muscle in Cancer Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Muscle fatty acid content
研究概览
简要总结
This study evaluates a nutritional supplement in the treatment of pancreatic cancer in adults. Half of the participants will receive the nutritional supplement, while the other half will receive a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a newly diagnosed pancreatic tumor thought to be pancreatic cancer scheduled for resection of the tumor.
- •Patients with a newly diagnosed pancreatic tumor thought to be pancreatic cancer, subsequently found to have biliary or ampullary cancer upon full pathological review, scheduled for resection of the tumor.
- •Patients with a CT image, which includes scans of the 3rd lumbar region, taken within 45 days before tumor resection surgery.
- •Ability to maintain oral intake.
- •Ability to give written, informed consent.
排除标准
- •Patients found to have a diagnosis other than pancreatic, biliary, or ampullary cancer upon full pathological review.
- •Patients with a benign tumor.
- •Patients taking drugs that modify muscle metabolism.
- •Patients with uncontrolled jaundice.
- •A compliance rate of <80%, excluding compliance during recovery from tumor resection surgery while in the hospital.
- •Patients currently taking the nutritional supplement being investigated in this study.
- •Patients in the placebo group who have plasma levels of the nutritional supplement components within the range of the nutritional supplement group at study time points when plasma levels of the nutritional supplement components are significantly higher in the nutritional supplement group versus the placebo group.
- •Inadequate specimens.
- •Known allergy to gelatin or glycerin.
结局指标
主要结局
Muscle fatty acid content
时间窗: At time of tumor removal surgery
Quantification of muscle triglyceride fatty acid (ug/g)
次要结局
- Plasma C-reactive protein(Baseline (before initiation of capsule consumption), day of tumor removal surgery (an average of 2-5 weeks from baseline), and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery))
- Plasma levels of the nutritional supplement(Baseline (before initiation of capsule consumption), day of tumor removal surgery (an average of 2-5 weeks from baseline), and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery))
- Determine computed tomography (CT)-derived body composition(Within 45 days before tumor removal surgery, and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery))
研究者
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