Oral Immunonutrition Therapy to Reduce Acute Toxicity After Neoadjuvant Chemoradiotherapy Pancrea… (NCT06736678) | Clinical Trial Compass
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Oral Immunonutrition Therapy to Reduce Acute Toxicity After Neoadjuvant Chemoradiotherapy Pancreatic Cancer Patients
China98 participantsStarted 2024-08-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence rate of grade 3 or higher acute toxicity related to neoadjuvant chemoradiotherapy