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2023-06-01
2024-07-30
2024-07-30
100
NCT07057843
The First Hospital of Hebei Medical University
The First Hospital of Hebei Medical University
INTERVENTIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-07-01 | N/A | 2025-07-01 |
2025-07-01 | N/A | 2025-07-10 |
2025-07-10 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 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 | BEHAVIORAL: Sequential Nutrition Intervention
DRUG: Enteral Nutrition Emulsion
|
| ACTIVE_COMPARATOR: 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). | BEHAVIORAL: Routine Nutritional Intervention
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Change in Quality of Life (QoL) | 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. | Assessed at baseline (pre-intervention) and one week after intervention. |
| Incidence of Postoperative Complications | The number and percentage of participants experiencing postoperative complications, including malnutrition, pancreatic fistula, local pain, gastrointestinal reactions, skin burns, and hemorrhage. | Monitored for two weeks post-intervention. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
60 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
