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
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
- Appetite enhancers, pregnancy promoters, steroids (nasal inhalation, topical andoptical steroids are acceptable);
- Anti-inflammatory fat emulsions or other oral nutritional supplementations/drugscontaining Omega-3 fatty acids, protein, glutamine, or arginine.
- 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
Connect with a study center
Beijing Cancer Hospital
Beijing, 100142
ChinaSite Not Available
Beijing Hospital
Beijing, 100005
ChinaSite Not Available
Beijing Tsinghua Changgung Hospital
Beijing, 102218
ChinaSite Not Available
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing, 100005
ChinaSite Not Available
Peking University People's Hospital
Beijing, 100044
ChinaSite Not Available
The Six Afffilated Hospital Sun Yat-sen University
Guangzhou, 510665
ChinaSite Not Available
The Affiliated Hospital of Qingdao University
Qingdao, 266003
ChinaSite Not Available
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200127
ChinaSite Not Available
Zhongshan Hospital Affiliated to Shanghai Fudan University
Shanghai, 200031
ChinaSite Not Available

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