Effect of a Food for Special Medical Purpose (FSMP) Product During the Perioperative Period in Patients With Digestive Tract Tumor

Abbott Nutrition8 sites in 1 country326 target enrollmentJune 24, 2022

ConditionsGastrointestinal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastrointestinal Cancer
Sponsor: Abbott Nutrition
Enrollment: 326
Locations: 8
Primary Endpoint: Serum Pre-Albumin
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, randomized, controlled, unblinded, parallel, multicenter, and non-inferiority study to demonstrate the safety and efficacy of a Food for Special Medical Purpose product (FSMP) in participants with digestive tract tumor undergoing surgical resection during the perioperative period.

Detailed Description

This is a prospective, randomized, controlled, unblinded, parallel, and multicenter, and non-inferiority study to demonstrate the safety and efficacy of a FSMP in participants with digestive tract tumor undergoing surgical resection during the perioperative period. Half of the participants will receive FSMP, the other half will receive Enteral Nutrition Emulsion (TPF-T) as an active control. Prealbumin, albumin, C-reactive protein (CRP), immunology parameters, vital signs, nutrition and safety-related laboratory parameters, compliance, and Adverse Events (AEs) will be evaluated in this study, to demonstrate its parity with TPF-T on efficacy and safety.

Registry

clinicaltrials.gov

Start Date

June 24, 2022

End Date

January 9, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant is male or female, between 18 and 75 years old, female participant is non-pregnant or non- lactating, at least 6 weeks postpartum
•Participants with digestive tract tumors diagnosed by histological method or radiological diagnosis and scheduled to undergo surgical resection
•Participant with NRS-2002 score ≥3
•Participant is willing to comply with the study protocol, able and willing to consume study product according to the protocol
•Participants with Body Mass Index 18.5 - 30 kg/m2
•Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study

Exclusion Criteria

•Participant has an expected life expectancy \< 3 months
•Participant has contraindications to enteral nutrition (such as active gastrointestinal hemorrhage, bowel obstruction, decompensated short bowel syndrome, high flow intestinal fistula, severe intraperitoneal infection, severe gastrointestinal emptying disorder, unstable vital signs, dyscoagulation, severe nausea, vomiting and/or uncontrolled diarrhea/steatorrhoea) that in the opinion of the study physician cannot be corrected
•Participant used parenteral nutrition or had plasma infused, RBC infused, albumin infused, amino acid infused or undergone radiotherapy and/or chemotherapy within 1 week before screening
•Participant with serum Albumin \<2.5g/dl at the time of the screening
•Participant has moderate to severe anemia, i.e. Hgb \< 90g / L
•Patients who plan to receive endoscopic tumor resection or / and palliative surgery
•Participant has renal dysfunction (serum creatinine \> 2 times the upper limit of normal (ULN))
•Participant has liver insufficiency \[serum alanine transaminase (ALT) and/or aspartate transaminase (AST) \> 2 times the ULN or severe cholestasis (conjugated bilirubin \> 2 times the ULN)\]
•Participant has severe cardiac insufficiency (e.g., Severe arrhythmia or atrial fibrillation; myocardial ischemia or stent surgery with unstable cardiac function within 3 months prior to screening visit )
•Participant states that he/she has had a significant cardiovascular and cerebrovascular event (e.g., myocardial infarction, stroke) within six months prior to screening visit; or stated history of congestive heart failure