- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05301556
Food for Special Medical Purpose in Patients With Digestive Tract Tumor
Effect of a Food for Special Medical Purpose (FSMP) Product During the Perioperative Period in Patients With Digestive Tract Tumor
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Beijing, China, 100142
- Beijing Cancer Hospital
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Beijing, China, 100044
- Peking University People's Hospital
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Beijing, China, 102218
- Beijing Tsinghua Changgung Hospital
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Beijing, China, 100005
- Beijing Hospital
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Beijing, China, 100021
- Cancer Hospital Chinese Academy of Medical Sciences
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Beijing, China, 100005
- Peking Union Medical College Hospital
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Guangzhou, China, 510665
- The Six Afffilated Hospital Sun Yat-sen University
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Qingdao, China, 266003
- The Affiliated Hospital of Qingdao University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- Appetite enhancers, pregnancy promoters, steroids (nasal inhalation, topical and optical steroids are acceptable);
- Anti-inflammatory fat emulsions or other oral nutritional supplementations/drugs containing Omega-3 fatty acids, protein, glutamine, or arginine.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Product
Food for Special Medical Purpose (FSMP) is a special medical food for patients with tumors
|
|
Active Comparator: Control Product
Nutrition Emulsion (TPF-T) TPF-T is a tumor-specific enteral nutrition therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Pre-Albumin
Time Frame: Baseline to Post Op Day (POD) 9
|
Change in pre-albumin
|
Baseline to Post Op Day (POD) 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Albumin
Time Frame: Baseline to Post Op Day (POD) 9
|
Change in albumin
|
Baseline to Post Op Day (POD) 9
|
Weight
Time Frame: Baseline to Post Op Day (POD) 9
|
Change in weight
|
Baseline to Post Op Day (POD) 9
|
Nutritional Risk Screening (NRS) 2002
Time Frame: Baseline to Post Op Day (POD) 9
|
NRS-2002 scored from 0 Low Risk to 7 High Risk
|
Baseline to Post Op Day (POD) 9
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-reactive Protein (CRP)
Time Frame: Baseline to Post Op Day (POD) 9
|
Change in CRP
|
Baseline to Post Op Day (POD) 9
|
Length of hospital stay
Time Frame: From Date of Admission until Date of Discharge, typically up to 14 days
|
Days stay in hospital
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From Date of Admission until Date of Discharge, typically up to 14 days
|
Hand Grip Strength
Time Frame: Baseline to Post Op Day (POD) 9
|
Measured in kg
|
Baseline to Post Op Day (POD) 9
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame: Baseline to Post Op Day (POD) 9
|
Healthcare Professional assessed score with range from 0 to 5; higher scores indicate worsening functional status
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Baseline to Post Op Day (POD) 9
|
Product Intake
Time Frame: Baseline to Post Op Day (POD) 9
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Daily volume of study product consumed
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Baseline to Post Op Day (POD) 9
|
Adverse Events
Time Frame: Baseline to Post Op Day (POD) 9
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Reported adverse events for assessment of safety and tolerability
|
Baseline to Post Op Day (POD) 9
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Shengqi Li, PhD, Abbott Nutrition
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BL43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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