Food for Special Medical Purpose in Patients With Digestive Tract Tumor

Last updated: February 29, 2024
Sponsor: Abbott Nutrition
Overall Status: Completed

Phase

N/A

Condition

Colon Cancer

Gastric Ulcers

Stomach Cancer

Treatment

Experimental Product

Control Product

Clinical Study ID

NCT05301556
BL43
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is male or female, between 18 and 75 years old, female participant isnon-pregnant or non- lactating, at least 6 weeks postpartum
  • Participants with digestive tract tumors diagnosed by histological method orradiological 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 consumestudy 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), approvedby an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior toany participation in the study

Exclusion

Exclusion Criteria:

  • Participant has an expected life expectancy < 3 months
  • Participant has contraindications to enteral nutrition (such as activegastrointestinal hemorrhage, bowel obstruction, decompensated short bowel syndrome,high flow intestinal fistula, severe intraperitoneal infection, severegastrointestinal emptying disorder, unstable vital signs, dyscoagulation, severenausea, vomiting and/or uncontrolled diarrhea/steatorrhoea) that in the opinion of thestudy physician cannot be corrected
  • Participant used parenteral nutrition or had plasma infused, RBC infused, albumininfused, amino acid infused or undergone radiotherapy and/or chemotherapy within 1week 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 ofnormal (ULN))
  • Participant has liver insufficiency [serum alanine transaminase (ALT) and/or aspartatetransaminase (AST) > 2 times the ULN or severe cholestasis (conjugated bilirubin > 2times the ULN)]
  • Participant has severe cardiac insufficiency (e.g., Severe arrhythmia or atrialfibrillation; myocardial ischemia or stent surgery with unstable cardiac functionwithin 3 months prior to screening visit )
  • Participant states that he/she has had a significant cardiovascular andcerebrovascular event (e.g., myocardial infarction, stroke) within six months prior toscreening 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 mayinterfere with study product consumption or compliance with study protocol procedures
  • Participant has a known history of allergy or intolerance to any ingredient in theinvestigational products
  • Participant is currently undergoing tumor immunotherapy taking medications/substancesthat could profoundly modulate appetite, metabolism or inflammatory level
  1. Appetite enhancers, pregnancy promoters, steroids (nasal inhalation, topical andoptical steroids are acceptable);
  2. Anti-inflammatory fat emulsions or other oral nutritional supplementations/drugscontaining Omega-3 fatty acids, protein, glutamine, or arginine.
  3. Dexamethasone, growth hormone or other drugs affecting metabolism;
  • Participant is currently undergoing tumor immunotherapy or takingmedications/substances that could profoundly modulate immune function, such as PD1 orPDL1 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 thescreening visit.

Study Design

Total Participants: 326
Treatment Group(s): 2
Primary Treatment: Experimental Product
Phase:
Study Start date:
June 24, 2022
Estimated Completion Date:
January 09, 2024

Study 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.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

  • Beijing Hospital

    Beijing, 100005
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing, 102218
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100005
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, 100044
    China

    Site Not Available

  • The Six Afffilated Hospital Sun Yat-sen University

    Guangzhou, 510665
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266003
    China

    Site Not Available

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200127
    China

    Site Not Available

  • Zhongshan Hospital Affiliated to Shanghai Fudan University

    Shanghai, 200031
    China

    Site Not Available

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