Sequential Nutrition Intervention for Pancreatic Cancer Patients Undergoing CyberKnife Radiotherapy

Hebei Medical University

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Behavioral: Routine Nutritional Intervention; Behavioral: Sequential Nutrition Intervention; Drug: Enteral Nutrition Emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT07057843

2023S00226

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental: Study Group

Experimental group

Description:

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.

Treatment:

Drug: Enteral Nutrition Emulsion

Behavioral: Sequential Nutrition Intervention

Active Comparator: Control Group

Active Comparator group

Description:

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).

Treatment:

Behavioral: Routine Nutritional Intervention