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NCT Number: NCT07057843

Sequential Nutrition Intervention for Pancreatic Cancer Patients Undergoing CyberKnife Radiotherapy

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Enteral Nutrition Emulsion

Drug

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

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).

Primary outcomes

  1. Change in Nutritional Indicators

    Time frame: 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).

  2. Change in Immune Function Indicators

    Time frame: 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+).

Secondary outcomes

  1. Change in Quality of Life (QoL)

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

    Change from baseline in QoL scores, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The score ranges from 0-100, with higher scores indicating better QoL.

  2. Incidence of Postoperative Complications

    Time frame: Monitored for two weeks post-intervention.

    The number and percentage of participants experiencing postoperative complications, including malnutrition, pancreatic fistula, local pain, gastrointestinal reactions, skin burns, and hemorrhage.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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