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

ConditionsPancreatic CancerNeoadjuvant ChemoradiotherapyImmunonutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Oral Immunonutrition

    Dietary supplement

    Patients receive enteral immunonutrition, Oral Impact® Nestle for 6 weeks from one week before radiotherapy;

Treatment groups

98 Participants
are divided into 1 treatment group
Group A: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Nutritional Assessment

Patient-Generated Subjective Global Assessment（PG-SGA）

Time frame
Baseline, Week 3,5,7,9,13,17
3

Nutritional Risk

Nutritional Risk Screening 2002 (NRS 2002)

Time frame
Baseline, Week 3,5,7,9,13,17
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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