Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03123432
• Date of registration: 05/04/2017
• Prospective Registration: No
• Primary sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Public title: Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
• Scientific 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)
• Date of first enrolment: June 1, 2011
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03123432
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Taiwan

Contacts

• Name: Jaw-Yuan Wang, PhD
• Affiliation: Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Gastric Cancer

Intervention(s)

Dietary Supplement: standard diet

Dietary Supplement: immunomodulating nutrients enriched diet

Primary Outcome(s)

immunomodulating effects [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

Secondary Outcome(s)

blood alanine aminotransferase (ALT) in U/L [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood albumin in g/dL [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

body mass index (BMI) in kg/m^2 [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood glucose [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood sodium (Na) mEq/L [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood prealbumin in mg/dL [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood triglycerides (TG) in mg/dL [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

length of hospital stay after surgery [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood urine nitrogen [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

postoperative complications [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood cholesterol in mg/mL [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood low-density lipoprotein (LDL) in mg/mL [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood aspartate aminotransferase (AST) in U/L [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood high-density lipoprotein (HDL) in mg/mL [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

blood leukocyte count cells/µL [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

time to first bowel action [Time Frame: at discharge from the hospital or 14 days after surgery, whichever occurred first]

Secondary ID(s)

KMUHIRB-2011-05-01(II)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors