Oral Immunonutrition Therapy to Reduce Acute Toxicity After Neoadjuvant Chemoradiotherapy Pancreatic Cancer Patients

December 12, 2024 updated by: WeiWei Xiao, Sun Yat-sen University

Efficacy of Oral Immunonutrition Therapy in Reducing Acute Toxicity After Neoadjuvant Chemoradiotherapy Among Pancreatic Cancer Patients: a Prospective, Single-arm Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Contact:
          • Weiwei Xiao, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Dietary supplement: Oral Immunonutrition
Patients receive enteral immunonutrition, Oral Impact® Nestle for 6 weeks from one week before radiotherapy;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of grade 3 or higher acute toxicity related to neoadjuvant chemoradiotherapy
Time Frame: Baseline, week 17
Grading of acute toxicity would be assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Baseline, week 17

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usual Body Weight Percentage(UBW%)
Time Frame: Baseline, Week 3,5,7,9,13,17
The baseline weight would be considered as usual body weight. UBW%= current weight/usual weight ×100%
Baseline, Week 3,5,7,9,13,17
Nutritional Assessment
Time Frame: Baseline, Week 3,5,7,9,13,17
Patient-Generated Subjective Global Assessment（PG-SGA）
Baseline, Week 3,5,7,9,13,17
Nutritional Risk
Time Frame: Baseline, Week 3,5,7,9,13,17
Nutritional Risk Screening 2002 (NRS 2002)
Baseline, Week 3,5,7,9,13,17
Quality of Life
Time Frame: Baseline, Week 3,5,7,9,13,17
The European Organisation for Research and Treatment of Cancer quality of life (EORTC QLQ-C30)
Baseline, Week 3,5,7,9,13,17
Inflammatory Indexes
Time Frame: Baseline; Week 7;
The serum level of procalcitonin (PCT),C-reactive protein(CRP) , serum amyloid A(SAA).
Baseline; Week 7;
Immunological Indexes
Time Frame: Baseline; Week 7;
The white blood cell (WBC) count and neutrophil (NE) count.
Baseline; Week 7;
Disease Control Rate (DCR)
Time Frame: Baseline; Week 13,17;
Disease control rate (DCR) was defined as the percentage of CR+PR+SD among the patients who could be evaluated for efficacy.
Baseline; Week 13,17;
Resectable Status Rate
Time Frame: Baseline; Week 13,17;

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.
Baseline; Week 13,17;
Radiotherapy Interruption (RTI)
Time Frame: Week 3,5,7,9;
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.
Week 3,5,7,9;
Overall Survival (OS)
Time Frame: Week 17; Year 2;
Overall survival was calculated from the date of treatment to either the date of death or last follow-up.
Week 17; Year 2;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Weiwei Xiao, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2023-360-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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