Oral immunonutrition therapy for pancreatic cancer patients undergoing chemoradiotherapy
Efficacy of Oral Immunonutrition Therapy in Reducing Acute Toxicity After Neoadjuvant Chemoradiotherapy Among Pancreatic Cancer Patients: a Prospective, Single-arm Clinical Trial
This study is testing if a special nutrition plan can help people with pancreatic cancer feel better and handle the side effects while they are getting chemotherapy and radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT06736678 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of oral immunonutrition therapy in reducing acute toxicity in patients with pancreatic cancer who are receiving neoadjuvant chemoradiotherapy. It is a prospective, single-arm trial that will enroll 98 patients, all of whom will receive the immunonutrition treatment for six weeks starting one week before their radiotherapy. The study aims to assess both the efficacy and safety of this nutritional intervention over a total follow-up period of four months. The focus is on improving patient outcomes by potentially mitigating the side effects associated with cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed pancreatic ductal epithelial malignant tumors who are undergoing neoadjuvant chemoradiotherapy.
Not a fit: Patients with known allergies to the components of the oral immunonutrition or those with contraindications for antineoplastic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the acute toxicity experienced by pancreatic cancer patients during chemoradiotherapy, improving their quality of life.
How similar studies have performed: While studies have shown success with immunonutrition in other cancer types, this approach specifically for pancreatic cancer during chemoradiotherapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Weiwei Xiao — Sun Yat-sen University
- Study coordinator: Weiwei Xiao
- Email: xiaoww@sysucc.org.cn
- Phone: +86 020 8734 0951
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.