RecruitingNot ApplicableNCT06736678

Oral Immunonutrition Therapy to Reduce Acute Toxicity After Neoadjuvant Chemoradiotherapy Pancreatic Cancer Patients

Efficacy of Oral Immunonutrition Therapy in Reducing Acute Toxicity After Neoadjuvant Chemoradiotherapy Among Pancreatic Cancer Patients: a Prospective, Single-arm Clinical Trial

Sponsor

Sun Yat-sen University

Enrollment

98 participants

Start Date

Aug 26, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Neoadjuvant Chemoradiotherapy Immunonutrition

Summary

A prospective, single-arm clinical trial is conducted to investigate the role of oral immunonutrion in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

\. Pathologically confirmed pancreatic ductal epithelial malignant tumors;
\. Resectable pancreatic cancer treated with neoadjuvant chemoradiotherapy, or nonresectable locally advanced pancreatic cancer treated with neoadjuvant or radical chemoradiotherapy;
Nutritional Risk Screening 2002 (NRS2002) ≥3 and Patient-Generated Subjective Global Assessment (PG-SGA) performance status B;
\. Age 18 years and older;
\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
\. Expected survival time more than 3 months;
\. History of antineoplastic therapy;

Exclusion Criteria10

\. Known allergy or intolerance to any component of investigational Oral Immunonutrition;
\. History of Oral Immunonutrition use within one month prior to enrollment;
\. Tumor compresses the major duodenal papilla, and /or appeared jaundice, acute pancreatitis;
\. Patients with contraindications for antineoplastic therapy, such as coronary heart disease, cerebral infarction, cerebral hemorrhage or other serious diseases;
\. Liver, kidney and blood coagulation function failure;
\. Patients with hemopathy;
\. Patients with active infections;
\. Patients with other primary tumor;
\. Patients with other medical diseases that seriously affected nutritional status;
Subjects deemed by the investigator have other factors that may be ineligible for enrollment;