Food for Special Medical Purpose in Patients With Digestive Tract Tumor

NCT05301556 | Completed

• 1 other identifier: BL43
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 8

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.

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• Serum Pre-Albumin

  Change in pre-albumin

  Baseline to Post Op Day (POD) 9

Secondary Outcomes (3)

• Serum Albumin

  Baseline to Post Op Day (POD) 9

• Weight

  Baseline to Post Op Day (POD) 9

• Nutritional Risk Screening (NRS) 2002

  Baseline to Post Op Day (POD) 9

Other Outcomes (6)

• C-reactive Protein (CRP)

  Baseline to Post Op Day (POD) 9

• Length of hospital stay

  From Date of Admission until Date of Discharge, typically up to 14 days

• Hand Grip Strength

  Baseline to Post Op Day (POD) 9

Study Arms (2)

Experimental Product

EXPERIMENTAL

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

Other: Experimental Product

Control Product

ACTIVE COMPARATOR

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

Other: Control Product

Interventions

Experimental Product 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

Experimental Product

Control Product 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

Control Product

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (8)

Beijing Hospital

Beijing, 100005, China

Location

Peking Union Medical College Hospital

Beijing, 100005, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, 102218, China

Location

The Six Afffilated Hospital Sun Yat-sen University

Guangzhou, 510665, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, 266003, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Shengqi Li, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 29, 2022
• Study Start: June 24, 2022
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)