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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Enteral Nutrition Emulsion | Drug | Fresubin (500 mL/bottle) administered at 30 mL/kg/day during the initial post-CyberKnife phase if required. |
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| 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). |
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| 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. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |