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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;