To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer (NCT05606848) | Clinical Trial Compass
RecruitingNot Applicable
To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
China350 participantsStarted 2022-11-30
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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;
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);
What they're measuring
1
Change in serum prealbumin
Timeframe: from baseline to close out visit (Post-operation Day 5-8)
Trial details
NCT IDNCT05606848
SponsorFresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd