An interventional study of Oral Immunonutrition in Pancreatic Cancer, Neoadjuvant Chemoradiotherapy and Immunonutrition, sponsored by Sun Yat-sen University. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Prevention
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.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 98 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Oral Immunonutrition
Patients receive enteral immunonutrition, Oral Impact® Nestle for 6 weeks from one week before radiotherapy;
Incidence rate of grade 3 or higher acute toxicity related to neoadjuvant chemoradiotherapy
Grading of acute toxicity would be assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: Baseline, week 17
Usual Body Weight Percentage(UBW%)
The baseline weight would be considered as usual body weight. UBW%= current weight/usual weight ×100%
Time frame: Baseline, Week 3,5,7,9,13,17
Nutritional Assessment
Patient-Generated Subjective Global Assessment（PG-SGA）
Time frame: Baseline, Week 3,5,7,9,13,17
Nutritional Risk
Nutritional Risk Screening 2002 (NRS 2002)
Time frame: Baseline, Week 3,5,7,9,13,17
Quality of Life
The European Organisation for Research and Treatment of Cancer quality of life (EORTC QLQ-C30)
Time frame: Baseline, Week 3,5,7,9,13,17
Inflammatory Indexes
The serum level of procalcitonin (PCT),C-reactive protein(CRP) , serum amyloid A(SAA).
Time frame: Baseline; Week 7;
Immunological Indexes
The white blood cell (WBC) count and neutrophil (NE) count.
Time frame: Baseline; Week 7;
Disease Control Rate (DCR)
Disease control rate (DCR) was defined as the percentage of CR+PR+SD among the patients who could be evaluated for efficacy.
Time frame: Baseline; Week 13,17;
Resectable Status Rate
Incidence rate of conversion from unresectable to resectable status after radiotherapy. Resectable status was defined according to the National Comprehensive Cancer Network (NCCN) Guidelines Version 1 2012. Tumors considered resectable were defined by the following objective criteria: (1) no distant metastases, (2)venous involvement of the portal vein demonstrating tumor abutment with impingement and narrowing of the lumen, encasement of the superior mesenteric vein (SMV)/portal vein allowing for safe resection and reconstruction, (3) no extension to the celiac axis, (4) tumor abutment of the SMA not to exceed \>180° of the circumference of the vessel wall.
Time frame: Baseline; Week 13,17;
Radiotherapy Interruption (RTI)
Radiotherapy interruption (RTI) often occurs because of severe acute treatment-related toxicity, disease progression, and patients' treatment compliance. RTI was defined as the difference between radiation treatment time and planned radiation time.
Time frame: Week 3,5,7,9;
Overall Survival (OS)
Overall survival was calculated from the date of treatment to either the date of death or last follow-up.
Time frame: Week 17; Year 2;
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sun Yat-sen University