Gastric Cancer
Conditions
Keywords
immunomodulating nutrients
Brief summary
The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major surgery in a single medical center.
Detailed description
Primary Objective: 1. The primary end points: To evaluate the effect of immunomodulating diets on the postoperative inflammatory response: including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α). 2. Secondary Objectives: (1). Biochemistry parameters: glucose,blood urine nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, sodium, and leukocyte count. (2). Nutritional status: albumin, prealbumin, BMI (3). Adverse events (4). Clinical outcomes: postoperative complications, time to first bowel action and length of hospital stay after surgery. Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach 15 patients at least in each. Plan of the Study: 1. This is a randomized, comparative, double blinded study in 2 arms. 2. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years. 3. Duration of Treatment: Treatment was administered before curative surgery for gastric adenocarcinoma or gastric GIST, and postoperative day 5-14 or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.
Interventions
DIETARY_SUPPLEMENTimmunomodulating nutrients enriched diet
DIETARY_SUPPLEMENTstandard diet
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age between 20-85 years old * Histologically proven primary gastric cancer or GIST. * Patients was planning to receive elective curative gastric surgery, such as partial gastrectomy, subtotal gastrectomy, proximal gastrectomy, total gastrectomy, etc. * Patient is able to understand the requirements of the study and written informed consent was obtained from each subject.
Exclusion criteria
* They were less than 20 years or over 85 years old * Hepatic dysfunction or bile stasis (serum total bilirubin \>2.5 mg/dL) * Renal dysfunction (serum creatinine \>1.5 mg/dL), or required hemodialysis * Cardiac dysfunction (NYHA functional class \>III, or stroke history) * Severe hypoalbuminemia (albumin \<2.5 g/dL) * Karnofsky performance status less than 60 * Overweight (body mass index \[BMI\] \>30 kg/m2) * Exhibited drug abuse or chronic alcoholism * Had life-threatening disease, or underwent emergent surgery * With infection or bowel obstruction * Pregnant or lactating * Had received chemotherapy within 14 days of the initiation of the trial * Had received immunosuppressive therapy or had immunological diseases recently * Had already participated in another clinical study with an investigational drug or an investigational medical device within a month of the initiation or during the study * Hypersensitive to casein, fish oil, soybean, or corn oil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| immunomodulating effects | at discharge from the hospital or 14 days after surgery, whichever occurred first | Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood urine nitrogen | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| blood aspartate aminotransferase (AST) in U/L | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| blood alanine aminotransferase (ALT) in U/L | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| blood triglycerides (TG) in mg/dL | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| blood cholesterol in mg/mL | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| blood low-density lipoprotein (LDL) in mg/mL | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| blood high-density lipoprotein (HDL) in mg/mL | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| blood glucose | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| blood leukocyte count cells/μL | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| blood albumin in g/dL | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| blood prealbumin in mg/dL | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| body mass index (BMI) in kg/m^2 | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
| postoperative complications | at discharge from the hospital or 14 days after surgery, whichever occurred first | postoperative complications that related to surgery |
| time to first bowel action | at discharge from the hospital or 14 days after surgery, whichever occurred first | interval of surgery to first bowel action (hours) |
| length of hospital stay after surgery | at discharge from the hospital or 14 days after surgery, whichever occurred first | length of hospital stay after surgery (days) |
| blood sodium (Na) mEq/L | at discharge from the hospital or 14 days after surgery, whichever occurred first | — |
Countries
Taiwan
Outcome results
None listed