Sequential Nutrition Intervention for Pancreatic Cancer Patients Undergoing CyberKnife Radiotherapy

NCT ID: NCT07057843

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-07-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sequential Nutrition Intervention

Intervention Type: BEHAVIORAL

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.

Enteral Nutrition Emulsion

Intervention Type: DRUG

Fresubin (500 mL/bottle) administered at 30 mL/kg/day during the initial post-CyberKnife phase if required.

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).

Group Type: ACTIVE_COMPARATOR

Routine Nutritional Intervention

Intervention Type: BEHAVIORAL

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).

Interventions

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.

Intervention Type: BEHAVIORAL

Enteral Nutrition Emulsion

Fresubin (500 mL/bottle) administered at 30 mL/kg/day during the initial post-CyberKnife phase if required.

Intervention Type: DRUG

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 ≥3.
• Expected survival >6 months.
• Karnofsky Performance Status (KPS) score ≥60.
• Provided written informed consent.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feifei Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2023S00226

Identifier Type: -

Identifier Source: org_study_id