NCT07057843

Sequential Nutrition Intervention for Pancreatic Cancer Patients Undergoing CyberKnife Radiotherapy

Application Value of Sequential Nutrition Intervention Guided by Nutritional Risk Screening in CyberKnife Radiotherapy for Pancreatic Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The First Hospital of Hebei Medical University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Sequential Nutrition Intervention	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.
DRUG	Enteral Nutrition Emulsion	Fresubin (500 mL/bottle) administered at 30 mL/kg/day during the initial post-CyberKnife phase if required.
BEHAVIORAL	Routine Nutritional Intervention	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).

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2025-07-10
• Last updated: 2025-07-10

Locations

1 site across 1 country: China