Clinical trial NCT03123432: Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
Official title: Combination of Arginine, Glutamine, and Omega-3 Fatty Acid Supplements for Perioperative Enteral Nutrition in Surgical Patients With Gastric Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: immunomodulating nutrients
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: immunomodulating effects
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary outcomes:
measure: blood glucose
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood urine nitrogen
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood aspartate aminotransferase (AST) in U/L
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood alanine aminotransferase (ALT) in U/L
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood triglycerides (TG) in mg/dL
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood cholesterol in mg/mL
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood low-density lipoprotein (LDL) in mg/mL
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood high-density lipoprotein (HDL) in mg/mL
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood sodium (Na) mEq/L
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood leukocyte count cells/μL
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood albumin in g/dL
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: blood prealbumin in mg/dL
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: body mass index (BMI) in kg/m^2
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: postoperative complications
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: time to first bowel action
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
measure: length of hospital stay after surgery
timeFrame: at discharge from the hospital or 14 days after surgery, whichever occurred first
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Study officials:
affiliation: Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
name: Jaw-Yuan Wang, PhD
role: STUDY_CHAIR
References: