Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 5:39 PM
Study NCT ID:
NCT03123432
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2017-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: