Food for Special Medical Purpose in Patients With Digestive Tract Tumor

NCT ID: NCT05301556

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-24
• Study Completion Date: 2024-01-09

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.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental Product

Food for Special Medical Purpose (FSMP) is a special medical food for patients with tumors

Group Type: EXPERIMENTAL

Experimental Product

Intervention Type: OTHER

• Before the surgery: FSMP provides daily target energy needed by participants
• 1-2 days after surgery: Start FSMP and advance as tolerated to achieve 20% of the daily target energy needed by participants
• 3rd-5th day after surgery: Gradually increase FSMP intake every day as tolerated to provide 30-80% of the daily target energy needed by participants
• 6th to 11th day after surgery. FSMP provides daily target energy needed by participants

Control Product

Nutrition Emulsion (TPF-T) TPF-T is a tumor-specific enteral nutrition therapy

Group Type: ACTIVE_COMPARATOR

Control Product

Intervention Type: OTHER

• Before surgery: TPF-T provides daily target energy needed by participants
• 1-2 days after surgery: Start TPF-T and advance as tolerated to achieve 20% of the daily target energy needed by participants
• 3rd-5th day after surgery: Gradually increase TPF-T intake every day as tolerated to provide 30-80% of the daily target energy needed by participants
• 6th to 11th day after surgery. TPF-T provides daily target energy needed by participants

Interventions

Experimental Product

• Before the surgery: FSMP provides daily target energy needed by participants
• 1-2 days after surgery: Start FSMP and advance as tolerated to achieve 20% of the daily target energy needed by participants
• 3rd-5th day after surgery: Gradually increase FSMP intake every day as tolerated to provide 30-80% of the daily target energy needed by participants
• 6th to 11th day after surgery. FSMP provides daily target energy needed by participants

Intervention Type: OTHER

Control Product

• Before surgery: TPF-T provides daily target energy needed by participants
• 1-2 days after surgery: Start TPF-T and advance as tolerated to achieve 20% of the daily target energy needed by participants
• 3rd-5th day after surgery: Gradually increase TPF-T intake every day as tolerated to provide 30-80% of the daily target energy needed by participants
• 6th to 11th day after surgery. TPF-T provides daily target energy needed by participants

Intervention Type: OTHER

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
• Participant with type I diabetes, or type II diabetes with fasting blood glucose ≥8mmol/L
• Participant has history of significant neurological or psychiatric disorder
• Participant has history of alcoholism, drug abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
• Participant has a known history of allergy or intolerance to any ingredient in the investigational products
• Participant is currently undergoing tumor immunotherapy taking medications/substances that could profoundly modulate appetite, metabolism or inflammatory level

1. Appetite enhancers, pregnancy promoters, steroids (nasal inhalation, topical and optical steroids are acceptable);

2. Anti-inflammatory fat emulsions or other oral nutritional supplementations/drugs containing Omega-3 fatty acids, protein, glutamine, or arginine.

3. Dexamethasone, growth hormone or other drugs affecting metabolism;

• Participant is currently undergoing tumor immunotherapy or taking medications/substances that could profoundly modulate immune function, such as PD1 or PDL1 inhibitors; CTLA-4 inhibitor; Thymosin; Azathioprine; Cyclosporine; Tacrolimus; Tumor necrosis factor antagonist; Lentinan; immune-modulating Chinese medicine
• Participant with active tuberculosis and HIV infection
• Participant participated in any clinical trial within four weeks prior to the screening visit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shengqi Li, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

Beijing Hospital

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Peking University People's Hospital

Beijing, , China

Beijing Cancer Hospital

Beijing, , China

Beijing Tsinghua Changgung Hospital

Beijing, , China

The Six Afffilated Hospital Sun Yat-sen University

Guangzhou, , China

The Affiliated Hospital of Qingdao University

Qingdao, , China

Countries

China

Other Identifiers

BL43

Identifier Type: -

Identifier Source: org_study_id