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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
350
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.
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.
Beijing Hospital
Beijing, China
RECRUITINGBeijing Cancer Hospital
Beijing, China
Change in serum prealbumin
Time frame: from baseline to close out visit (Post-operation Day 5-8)
Change in body weight (%)
Time frame: from baseline to Visit 2(Pre-operation Day 1), Visit 4(Post-operation Day 5 or 6) and close out visit(Post-operation Day 5-8)
Change in serum prealbumin
Time frame: 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
Time frame: from baseline to Visit 3(Post-operation Day 1) and close out visit(Post-operation Day 5-8)
Change in BMI
weight in kilograms, height in meters,weight and height will be combined to report BMI in kg/m\^2
Time frame: from baseline to close out visit(Post-operation Day 5-8)
Change in PG-SGA
Time frame: from baseline to Close out Visit(Post-operation Day 5-8)
Change in grip strength
hand grip strength measured in kg
Time frame: from baseline to Close out Visit(Post-operation Day 5-8)
Change in CRP
Time frame: from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 5-8)
Change in total lymphocyte count
Time frame: from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 5-8)
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Capital Medical University Affiliated Beijing Shijitan Hospital
Beijing, China
RECRUITINGPeking University People's Hospital
Beijing, China
RECRUITINGXiangya Hospital Central South University
Changsha, China
RECRUITINGThe First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, China
RECRUITINGNanfang Hospital
Guanzhou, China
RECRUITINGYunnan Cancer Hospital(The affiliated hospital of Kunming medical university)
Kunming, China
RECRUITINGJiangsu Province Hospital of Chinese Medicine
Nanjing, China
RECRUITINGThe Affiliated Hospital of Qingdao University
Qingdao, China
RECRUITING...and 4 more locations
Change in total number of CD4+and CD8+
Time frame: from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 5-8)
Change in CD4+ % and CD8+%
the respective percentage of CD4+ T lymphocytes and CD8+ T lymphocytes in total lymphocytes
Time frame: from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 5-8)
Change in CD4+ T lymphocytes /CD8+ T lymphocytes
Time frame: from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 5-8)
Change in neutrophil/lymphocyte ratio
Time frame: from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 5-8)
Change in blood glucose
Time frame: from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 5-8)
Change in lipids
Time frame: from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 5-8)
Change in ECOG performance status
Time frame: from baseline to Close out Visit(Post-operation Day 5-8)
All adverse events (AEs), including serious adverse events (SAEs) for assessment of safety and tolerability
Time frame: from baseline to Close out Visit(Post-operation Day 5-8)
Energy intake in kcal / kg BW
Total volume of IMP consumed
Time frame: from baseline to Close out Visit(Post-operation Day 5-8)