To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer

Study Overview
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Brief Summary
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This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. Aim of the study is to evaluate the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal cancer undergoing surgical resection during the perioperative period.

Detailed Description
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This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. The IMP includes study product and control product. The study product will be Fresubin Support Drink (FSMP), the control product will be Enteral Nutrition Emulsion(TPF-T) . 250 patients will be randomly assigned to the Fresubin Support Drink (FSMP) group or Enteral Nutrition Emulsion(TPF-T) group at a ratio of 1:1. 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.

Official Title
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Efficacy and Safety of Fresubin Support Drink for Enteral Nutrition Support in Perioperative Patients With Gastrointestinal Cancer: A Prospective, Randomized, Open-Label, Active-Controlled Multi-Center Clinical Trial

Conditions
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Gastrointestinal Cancer

Intervention / Treatment
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* Other: Nutrition Emulsion (TPF-T)
* Other: Foods for special medical purposes [FSMP] for patients with tumors


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Agreed to participate in the study with signed ICF; Age 18-75 years; Patient has gastrointestinal cancer confirmed by histological or imagological method and scheduled for resection via open or laparoscopic surgery; Radiotherapy and/or Chemotherapy was not performed within 2 weeks before screening; Hemoglobin ≥ 90 g/L Albumin ≥ 2.5 g/dL BMI ≥18.5 and ≤29 kg/m2; ECOG Performance status 0-2 preoperatively; Life expectancy >6 months. Exclusion criteria Contraindication or intolerance against EN, e.g., acute gastrointestinal bleeding, ileus (Grade≥3 NCI-CTCAE v 5.0); Any congenital defect of amino acid or carbohydrate metabolism, such as phenylalaninemia, galactosaemia; Conditions requiring emergency surgery; Conditions other than cancer and surgery that can be associated with loss of body weight e.g. serious active clinical infections (> Grade 2, NCI-CTCAE 5.0), including active tuberculosis, or self-reported HIV infection or active hepatitis B or C; Known treatment refractory metabolic disease (e.g., poorly-controlled diabetes mellitus or fasting blood glucose≥ 10mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis); Cardiac dysfunction (New York Heart Association Functional Class > III); Severe hepatic dysfunction associated with significant increase of AST or ALT > 5 ULN or bilirubin > 3 ULN; Severe renal dysfunction associated with serum creatinine concentration > 1.5 ULN and/or required dialysis; Active treatment refractory bleeding; Other malignancies in the last 3 years (except for successfully treated in situ basocellular skin or in situ cervical uterine tumours); Known disease that could seriously affect the digestion and absorption of the IMPs; History of drug or alcohol abuse within 6 months prior to screening; Current use of medication or nutritional supplements containing more than 500 mg of EPA+DHA/day or fish oil capsules/ supplements containing more than 500 mg EPA + DHA/day at screening; Current use of muscle growth supporting substances (e.g., anabolics) at screening; Planned chemotherapy, radiotherapy or immunotherapy during the first 12 days following the surgical tumor resection; Transfusion of blood products within 1 week before screening; Known allergy to contents of the study product or control product; Pregnancy or lactation; Participation in another clinical study with an investigational drug, FSMP or an investigational medical device one month prior to start of study or planned participation in another clinical trial as specified before during the course of the study period; Patient who is unable to understand the spoken and written information or not willing or not able to comply with scheduled visits and the requirements of the study protocol; Considered not suitable for study participation by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control product<br>Nutrition Emulsion (TPF-T) is a tumor-specific enteral nutrition therapy | Other: Nutrition Emulsion (TPF-T)<br>* All patients will be randomized to receive the FSMP or control product. Before the surgery: Patients daily intake control product with recommended energy. 1-8 days after surgery: Patients gradually increase control product intake to reach the recommended energy.<br>|
| Experimental: Study prodcut<br>Foods for special medical purposes [FSMP] for patients with tumors | Other: Foods for special medical purposes [FSMP] for patients with tumors<br>* All patients will be randomized to receive the FSMP or control product. Before the surgery: Patients daily intake FSMP with recommended energy. 1-8 days after surgery: Patients gradually increase FSMP intake to reach the recommended energy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum prealbumin |  | from baseline to close out visit（Post-operation Day 8） | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight (%) |  | from baseline to Visit 2（Pre-operation Day 1）, Visit 3（Post-operation Day 1）,Visit 4（Post-operation Day 5 or 6） and close out visit（Post-operation Day 8） | 
| Change in serum prealbumin |  | from baseline to Visit 2（Pre-operation Day 1）, Visit 3（Post-operation Day 1） and Visit 4（Post-operation Day 5 or 6） | 
| Change in serum albumin |  | from baseline to Visit 3（Post-operation Day 1） and close out visit（Post-operation Day 8） | 
| Change in BMI | weight in kilograms, height in meters，weight and height will be combined to report BMI in kg/m^2 | from baseline to close out visit（Post-operation Day 8） | 
| Change in PG-SGA |  | from baseline to Close out Visit（Post-operation Day 8） | 
| Change in grip strength | hand grip strength measured in kg | from baseline to Close out Visit（Post-operation Day 8） | 
| Change in CRP |  | from baseline to Visit 3（Post-operation Day 1） and Close out Visit（Post-operation Day 8） | 
| Change in total lymphocyte count |  | from baseline to Visit 3（Post-operation Day 1） and Close out Visit（Post-operation Day 8） | 
| Change in total number of CD4+and CD8+ |  | from baseline to Visit 3（Post-operation Day 1） and Close out Visit（Post-operation Day 8） | 
| Change in CD4+ % and CD8+% | the respective percentage of CD4+ T lymphocytes and CD8+ T lymphocytes in total lymphocytes | from baseline to Visit 3（Post-operation Day 1） and Close out Visit（Post-operation Day 8） | 
| Change in CD4+ T lymphocytes /CD8+ T lymphocytes |  | from baseline to Visit 3（Post-operation Day 1） and Close out Visit（Post-operation Day 8） | 
| Change in neutrophil/lymphocyte ratio |  | from baseline to Visit 3（Post-operation Day 1） and Close out Visit（Post-operation Day 8） | 
| Change in blood glucose |  | from baseline to Visit 3（Post-operation Day 1） and Close out Visit（Post-operation Day 8） | 
| Change in lipids |  | from baseline to Visit 3（Post-operation Day 1） and Close out Visit（Post-operation Day 8） | 
| Change in ECOG performance status |  | from baseline to Close out Visit（Post-operation Day 8） | 
| All adverse events (AEs), including serious adverse events (SAEs) for assessment of safety and tolerability |  | from baseline to Close out Visit（Post-operation Day 8） | 
| Energy intake in kcal / kg BW | Total volume of IMP consumed | from baseline to Close out Visit（Post-operation Day 8） |