Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

Gastric Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123432
• Other study ID #: KMUHIRB-2011-05-01(II)
• Status: Completed
• Phase: N/A
• First received: April 5, 2017
• Last updated: April 20, 2017
• Start date: June 1, 2011
• Est. completion date: September 1, 2016

Study information

• Verified date: April 2017
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastrointestinal Stromal Tumors
• Stomach Neoplasms

Intervention

Dietary Supplement:
• immunomodulating nutrients enriched diet

• standard diet

Locations

Country	Name	City	State
Taiwan	Chung-Ho Memorial Hospital, Kaohsiung Medical University:	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunomodulating effects	Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-a (TNF-a) were employed to assess inflammatory processes.	at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood glucose		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood urine nitrogen		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood aspartate aminotransferase (AST) in U/L		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood alanine aminotransferase (ALT) in U/L		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood triglycerides (TG) in mg/dL		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood cholesterol in mg/mL		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood low-density lipoprotein (LDL) in mg/mL		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood high-density lipoprotein (HDL) in mg/mL		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood sodium (Na) mEq/L		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood leukocyte count cells/µL		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood albumin in g/dL		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	blood prealbumin in mg/dL		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	body mass index (BMI) in kg/m^2		at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	postoperative complications	postoperative complications that related to surgery	at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	time to first bowel action	interval of surgery to first bowel action (hours)	at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary	length of hospital stay after surgery	length of hospital stay after surgery (days)	at discharge from the hospital or 14 days after surgery, whichever occurred first