Efficacy of Oral Immunonutrition Therapy in Reducing Acute Toxicity After Neoadjuvant Chemoradiotherapy Among Pancreatic Cancer Patients: a Prospective, Single-arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Incidence rate of grade 3 or higher acute toxicity related to neoadjuvant chemoradiotherapy
研究概览
简要总结
A prospective, single-arm clinical trial is conducted to investigate the role of oral immunonutrion in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients.
详细描述
Pancreatic cancer has a poor prognosis for its high malignancy. Radical surgical resection is an effective means for prolonging survival. However, only a few patients can be directly treated with surgical resection. Neoadjuvant therapy can reduce the tumor size, improve the relationship between the tumor and adjacent blood vessels，to gain surgical opportunities and prolonging patients' survival.
Nutritional treatment of cancer has been valued by more and more researchers. As an important branch of nutrition therapy, immunonutrition plays an important role in regulating the immune. Studies have shown that immunonutrition can reduce antitumor treatment related toxicity among patients with head and neck cancer, esophageal cancer. At present, most studies on immunonutrition therapy focus on perioperative patients, and there is no study on patients with pancreatic cancer undergoing radiotherapy.
This prospective, single-arm clinical trial aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients. A total of 98 pancreatic cancer patients will be enrolled. All of the patients will receive oral immunonutrition therapy for 6 weeks from one week before radiotherapy. The total follow time is 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Pathologically confirmed pancreatic ductal epithelial malignant tumors;
- •Resectable pancreatic cancer treated with neoadjuvant chemoradiotherapy, or nonresectable locally advanced pancreatic cancer treated with neoadjuvant or radical chemoradiotherapy;
- •3.Nutritional Risk Screening 2002 (NRS2002) ≥3 and Patient-Generated Subjective Global Assessment (PG-SGA) performance status B;
- •Age 18 years and older;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •Expected survival time more than 3 months;
- •History of antineoplastic therapy;
排除标准
- •Known allergy or intolerance to any component of investigational Oral Immunonutrition;
- •History of Oral Immunonutrition use within one month prior to enrollment;
- •Tumor compresses the major duodenal papilla, and /or appeared jaundice, acute pancreatitis;
- •Patients with contraindications for antineoplastic therapy, such as coronary heart disease, cerebral infarction, cerebral hemorrhage or other serious diseases;
- •Liver, kidney and blood coagulation function failure;
- •Patients with hemopathy;
- •Patients with active infections;
- •Patients with other primary tumor;
- •Patients with other medical diseases that seriously affected nutritional status;
- •10.Subjects deemed by the investigator have other factors that may be ineligible for enrollment;
结局指标
主要结局
Incidence rate of grade 3 or higher acute toxicity related to neoadjuvant chemoradiotherapy
时间窗: Baseline, week 17
Grading of acute toxicity would be assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
次要结局
- Usual Body Weight Percentage(UBW%)(Baseline, Week 3,5,7,9,13,17)
- Nutritional Assessment(Baseline, Week 3,5,7,9,13,17)
- Nutritional Risk(Baseline, Week 3,5,7,9,13,17)
- Quality of Life(Baseline, Week 3,5,7,9,13,17)
- Inflammatory Indexes(Baseline; Week 7;)
- Immunological Indexes(Baseline; Week 7;)
- Disease Control Rate (DCR)(Baseline; Week 13,17;)
- Resectable Status Rate(Baseline; Week 13,17;)
- Radiotherapy Interruption (RTI)(Week 3,5,7,9;)
- Overall Survival (OS)(Week 17; Year 2;)
研究者
WeiWei Xiao
Chief physician
Sun Yat-sen University