Sequential Nutrition Intervention for Pancreatic Cancer Patients Undergoing CyberKnife Radiotherapy

NCT07057843 | Completed

• 1 other identifier: 2023S00226
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; CyberKnife; Radiotherapy; Sequential Nutrition Intervention; Nutritional Risk Screening; Nutritional Status; Immune Function

Outcome Measures

Primary Outcomes (2)

• Change in Nutritional Indicators

  Change from baseline in serum levels of Total Protein (TP), Transferrin (TRF), Albumin (ALB), and Prealbumin (PA).

  Assessed at baseline (pre-intervention) and one week after intervention.

• Change in Immune Function Indicators

  Change from baseline in peripheral blood levels of Immunoglobulin A (IgA), IgM, IgG, and T-cell subsets (CD3+, CD4+, CD8+).

  Assessed at baseline (pre-intervention) and one week after intervention.

Secondary Outcomes (2)

• 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.

Study Arms (2)

Experimental: Study Group

EXPERIMENTAL

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.

Behavioral: Sequential Nutrition Intervention; Drug: Enteral Nutrition Emulsion

Active Comparator: Control Group

ACTIVE COMPARATOR

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).

Behavioral: Routine Nutritional Intervention

Interventions

Sequential Nutrition Intervention 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.

Experimental: Study Group

Enteral Nutrition Emulsion DRUG

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

Experimental: Study Group

Routine Nutritional Intervention 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).

Active Comparator: Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: June 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

CN (1)