NCT06736678

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

December 17, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

December 12, 2024

Last Update Submit

December 12, 2024

Conditions

Pancreatic CancerNeoadjuvant ChemoradiotherapyImmunonutrition

Outcome Measures

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.

    Baseline, week 17

Secondary Outcomes (10)

  • Usual Body Weight Percentage(UBW%)

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

  • Nutritional Assessment

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

  • Nutritional Risk

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

  • Quality of Life

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

  • Inflammatory Indexes

    Baseline; Week 7;

  • +5 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL
Dietary Supplement: Oral Immunonutrition

Interventions

Oral ImmunonutritionDIETARY_SUPPLEMENT

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Pathologically confirmed pancreatic ductal epithelial malignant tumors;
  • \. Resectable pancreatic cancer treated with neoadjuvant chemoradiotherapy, or nonresectable locally advanced pancreatic cancer treated with neoadjuvant or radical chemoradiotherapy;
  • Nutritional Risk Screening 2002 (NRS2002) ≥3 and Patient-Generated Subjective Global Assessment (PG-SGA) performance status B;
  • \. Age 18 years and older;
  • \. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • \. Expected survival time more than 3 months;
  • \. History of antineoplastic therapy;

You may not qualify if:

  • \. Known allergy or intolerance to any component of investigational Oral Immunonutrition;
  • \. History of Oral Immunonutrition use within one month prior to enrollment;
  • \. Tumor compresses the major duodenal papilla, and /or appeared jaundice, acute pancreatitis;
  • \. Patients with contraindications for antineoplastic therapy, such as coronary heart disease, cerebral infarction, cerebral hemorrhage or other serious diseases;
  • \. Liver, kidney and blood coagulation function failure;
  • \. Patients with hemopathy;
  • \. Patients with active infections;
  • \. Patients with other primary tumor;
  • \. Patients with other medical diseases that seriously affected nutritional status;
  • Subjects deemed by the investigator have other factors that may be ineligible for enrollment;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Weiwei Xiao

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiwei Xiao

CONTACT

+86 020 8734 0951xiaoww@sysucc.org.cn

Liping Chen

CONTACT

+86 020 87340767chenlp@sysucc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

August 26, 2024

Primary Completion

June 30, 2025

Study Completion

September 30, 2025

Last Updated

December 17, 2024

Record last verified: 2024-07

Locations

CN(2)