NCT06736678

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Neoadjuvant Chemoradiotherapy
• Immunonutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral Immunonutrition	Patients receive enteral immunonutrition, Oral Impact® Nestle for 6 weeks from one week before radiotherapy;

Timeline

• Start date: 2024-08-26
• Primary completion: 2025-06-30
• Completion: 2025-09-30
• First posted: 2024-12-17
• Last updated: 2024-12-17

Locations

2 sites across 1 country: China