NCT05606848 To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
| NCT ID | NCT05606848 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd |
| Condition | Gastrointestinal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2022-11-30 |
| Primary Completion | 2025-03 |
Trial Parameters
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Brief Summary
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.
Eligibility 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
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