Application Value of Sequential Nutrition Intervention Guided by Nutritional Risk Screening in CyberKnife Radiotherapy for Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Nutritional Indicators
研究概览
简要总结
This study aims to evaluate the clinical value of a structured nutritional support program for patients with pancreatic cancer undergoing CyberKnife radiotherapy. The study compares a sequential nutrition intervention, guided by nutritional risk screening, against routine nutritional advice. The goal is to determine if the structured intervention can better improve patients' nutritional status, immune function, and quality of life, while reducing the rate of postoperative complications.
详细描述
Pancreatic cancer is a highly aggressive malignancy often associated with severe malnutrition, which compromises treatment tolerance and clinical outcomes. CyberKnife radiotherapy is an effective treatment for inoperable tumors, but can still impact patient's nutritional and immune status. While nutritional support is critical, a systematic, phased approach guided by risk screening is not well-established in this patient population. This single-center, prospective, randomized controlled trial was designed to address this gap. A total of 100 patients with pancreatic cancer and malnutrition (NRS2002 score ≥3) were randomly assigned to either a study group or a control group. The control group received routine dietary education. The study group received a comprehensive sequential nutrition intervention managed by a multidisciplinary team. This intervention included initial nutritional risk screening, tailored energy and protein targets calculated using the Harris-Benedict formula, a phased protocol for nutritional support before and after CyberKnife treatment (including oral nutritional supplements, enteral, and parenteral nutrition as needed), and continued post-discharge follow-up. The hypothesis is that this structured, sequential approach will significantly improve nutritional biomarkers, enhance immune function, lead to a better quality of life, and decrease complications compared to routine care.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of pancreatic cancer confirmed by pathological examination.
- •Capacity for oral intake.
- •Scheduled for CyberKnife treatment.
- •Presence of malnutrition, defined by Nutritional Risk Screening 2002 (NRS2002) score ≥
- •Expected survival >6 months.
- •Karnofsky Performance Status (KPS) score ≥
- •Provided written informed consent.
排除标准
- •Severe cardiovascular, hepatic, or renal dysfunction.
- •Concurrent malignancies of the digestive system.
- •Poor treatment compliance.
- •Severe ascites or edema.
- •Severe cognitive impairment hindering cooperation.
- •History of liver, kidney, or hematological diseases.
- •Bedridden status precluding nutritional assessment.
- •Long-term corticosteroid use.
- •Comorbidities affecting drug metabolism or excretion (e.g., AIDS, active hepatitis).
研究组 & 干预措施
Experimental: Study Group
Participants received a structured, sequential nutrition intervention guided by nutritional risk screening (NRS2002). A multidisciplinary team provided the intervention, which included:
- Pre-CyberKnife phase: Calculation of energy requirements using the Harris-Benedict formula, dietary guidance, and initiation of oral nutritional supplements (ONS). If oral intake was less than 60% of target, partial enteral (PEN) or parenteral nutrition (PPN) was administered for 7-10 days.
- Post-CyberKnife phase: Phased re-introduction of feeding, starting with enteral nutrition via nasojejunal tube (Day 1-2) and transitioning to an oral diet (Day 3 onwards).
- Post-discharge phase: Home energy targets were recalculated, with telephone/WeChat follow-up to ensure adherence. ONS prescribed if intake fell below 60% of targets.
干预措施: Sequential Nutrition Intervention (Behavioral)
Experimental: Study Group
Participants received a structured, sequential nutrition intervention guided by nutritional risk screening (NRS2002). A multidisciplinary team provided the intervention, which included:
- Pre-CyberKnife phase: Calculation of energy requirements using the Harris-Benedict formula, dietary guidance, and initiation of oral nutritional supplements (ONS). If oral intake was less than 60% of target, partial enteral (PEN) or parenteral nutrition (PPN) was administered for 7-10 days.
- Post-CyberKnife phase: Phased re-introduction of feeding, starting with enteral nutrition via nasojejunal tube (Day 1-2) and transitioning to an oral diet (Day 3 onwards).
- Post-discharge phase: Home energy targets were recalculated, with telephone/WeChat follow-up to ensure adherence. ONS prescribed if intake fell below 60% of targets.
干预措施: Enteral Nutrition Emulsion (Drug)
Active Comparator: Control Group
Participants received routine nutritional intervention, which consisted of dietary education focused on balanced, soft, and easily digestible meals rich in protein and other nutrients (e.g., high-protein soups).
干预措施: Routine Nutritional Intervention (Behavioral)
结局指标
主要结局
Change in Nutritional Indicators
时间窗: Assessed at baseline (pre-intervention) and one week after intervention.
Change from baseline in serum levels of Total Protein (TP), Transferrin (TRF), Albumin (ALB), and Prealbumin (PA).
Change in Immune Function Indicators
时间窗: Assessed at baseline (pre-intervention) and one week after intervention.
Change from baseline in peripheral blood levels of Immunoglobulin A (IgA), IgM, IgG, and T-cell subsets (CD3+, CD4+, CD8+).
次要结局
- Change in Quality of Life (QoL)(Assessed at baseline (pre-intervention) and one week after intervention.)
- Incidence of Postoperative Complications(Monitored for two weeks post-intervention.)
研究者
Feifei Wang
Principal Investigator
The First Hospital of Hebei Medical University