Clinical trial NCT06736678: Oral Immunonutrition Therapy to Reduce Acute Toxicity After Neoadjuvant Chemoradiotherapy Pancreatic Cancer Patients
Official title: Efficacy of Oral Immunonutrition Therapy in Reducing Acute Toxicity After Neoadjuvant Chemoradiotherapy Among Pancreatic Cancer Patients: a Prospective, Single-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Neoadjuvant Chemoradiotherapy
Immunonutrition
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed description: Pancreatic cancer has a poor prognosis for its high malignancy. Radical surgical resection is an effective means for prolonging survival. However, only a few patients can be directly treated with surgical resection. Neoadjuvant therapy can reduce the tumor size, improve the relationship between the tumor and adjacent blood vessels，to gain surgical opportunities and prolonging patients' survival.

Nutritional treatment of cancer has been valued by more and more researchers. As an important branch of nutrition therapy, immunonutrition plays an important role in regulating the immune. Studies have shown that immunonutrition can reduce antitumor treatment related toxicity among patients with head and neck cancer, esophageal cancer. At present, most studies on immunonutrition therapy focus on perioperative patients, and there is no study on patients with pancreatic cancer undergoing radiotherapy.

This prospective, single-arm clinical trial aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients. A total of 98 pancreatic cancer patients will be enrolled. All of the patients will receive oral immunonutrition therapy for 6 weeks from one week before radiotherapy. The total follow time is 4 months.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence rate of grade 3 or higher acute toxicity related to neoadjuvant chemoradiotherapy
timeFrame: Baseline, week 17
Secondary outcomes:
measure: Usual Body Weight Percentage(UBW%)
timeFrame: Baseline, Week 3,5,7,9,13,17
measure: Nutritional Assessment
timeFrame: Baseline, Week 3,5,7,9,13,17
measure: Nutritional Risk
timeFrame: Baseline, Week 3,5,7,9,13,17
measure: Quality of Life
timeFrame: Baseline, Week 3,5,7,9,13,17
measure: Inflammatory Indexes
timeFrame: Baseline; Week 7;
measure: Immunological Indexes
timeFrame: Baseline; Week 7;
measure: Disease Control Rate (DCR)
timeFrame: Baseline; Week 13,17;
measure: Resectable Status Rate
timeFrame: Baseline; Week 13,17;
measure: Radiotherapy Interruption (RTI)
timeFrame: Week 3,5,7,9;
measure: Overall Survival (OS)
timeFrame: Week 17; Year 2;
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Weiwei Xiao
role: PRINCIPAL_INVESTIGATOR
References: