Oral Immunonutrition Therapy to Reduce Acute Toxicity After Neoadjuvant Chemoradiotherapy Pancreatic Cancer Patients
NCT ID: NCT06736678
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
98 participants
INTERVENTIONAL
2024-08-26
2025-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Intervention group
Oral Immunonutrition
Patients receive enteral immunonutrition, Oral Impact® Nestle for 6 weeks from one week before radiotherapy;
Interventions
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Oral Immunonutrition
Patients receive enteral immunonutrition, Oral Impact® Nestle for 6 weeks from one week before radiotherapy;
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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WeiWei Xiao
Chief physician
Principal Investigators
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Weiwei Xiao
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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WeiWei xiao
Role: primary
Weiwei Xiao, Doctor
Role: primary
Weiwei Xiao, Doctor
Role: backup
Other Identifiers
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B2023-360-01
Identifier Type: -
Identifier Source: org_study_id