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

Fresenius Kabi

Status: Enrolling

Conditions: Gastrointestinal Cancer

Treatments: Other: Nutrition Emulsion (TPF-T); Other: Foods for special medical purposes [FSMP] for patients with tumors

Study type: Interventional

Funder types: Industry

Identifiers

NCT05606848

SUPE-001-CEN

Details and patient eligibility

About

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.

Full description

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) . Not exceed 350 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Agreed to participate in the study with signed ICF;
2. Age 18-75 years;
3. Patient has gastrointestinal cancer confirmed by histological or imagological method and scheduled for resection via open or laparoscopic surgery;
4. Radiotherapy and/or Chemotherapy was not performed within 2 weeks before screening;
5. Hemoglobin ≥ 90 g/L
6. Albumin ≥ 2.5 g/dL
7. BMI ≥18.5 and ≤29 kg/m2;
8. ECOG Performance status 0-2 preoperatively;
9. Expected survival time >6 months.

Exclusion criteria

1. Contraindication or intolerance against EN, e.g., acute gastrointestinal bleeding, ileus (Grade≥3 NCI-CTCAE v 5.0);
2. Any congenital defect of amino acid or carbohydrate metabolism, such as phenylalaninemia, galactosaemia;
3. Conditions requiring emergency surgery;
4. 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;
5. Known treatment refractory metabolic disease (e.g., poorly-controlled diabetes mellitus or fasting blood glucose≥ 10mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis);
6. Cardiac dysfunction (New York Heart Association Functional Class > III);
7. Severe hepatic dysfunction associated with significant increase of AST or ALT > 5 ULN or bilirubin > 3 ULN;
8. Severe renal dysfunction associated with serum creatinine concentration > 1.5 ULN and/or required dialysis;
9. Active treatment refractory bleeding;
10. Other malignancies in the last 3 years (except for successfully treated in situ basocellular skin or in situ cervical uterine tumours);
11. Known disease that could seriously affect the digestion and absorption of the IMPs;
12. History of drug or alcohol abuse within 6 months prior to screening;
13. 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;
14. Current use of muscle growth supporting substances (e.g., anabolics) at screening;
15. Planned chemotherapy, radiotherapy or immunotherapy during the first 12 days following the surgical tumor resection;
16. Transfusion of blood products within 1 week before screening;
17. Known allergy to contents of the study product or control product;
18. Pregnancy or lactation;
19. 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;
20. 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;
21. Considered not suitable for study participation by the investigator

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Control product

Active Comparator group

Description:

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

Treatment:

Other: Nutrition Emulsion (TPF-T)

Study prodcut

Experimental group

Description:

Foods for special medical purposes \[FSMP\] for patients with tumors

Treatment:

Other: Foods for special medical purposes [FSMP] for patients with tumors