Clinical trial NCT01704664: Perioperative Immunonutrition, Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients
Official title: Prospective Study of the Effect of Perioperative Immunonutrition on the Immune Host Defense and the Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: malnutrition,
perioperative artificial nutrition,
immunonutrition,
gastrectomy,
lymphocytes,
interleukin,
blood platelets,
phagocytic and bactericidal activity of blood platelets
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Perioperative immunonutrition in gastric cancer patients can reduce perioperative morbidity and may improve quality of their life. Patients with gastric cancer will be divided into four groups depending on the type of artificial nutrition. Group I (enteral feeding) and II (enteral feeding and parenteral nutrition with glutamine) will be administered nutritional therapy during the postoperative period, group III (oral arginine) and IV (parenteral immunonutrition) patients will be treated nutritionally both prior to and after the surgery. The lymphocytes and their subpopulations, interleukin IL-1B,-6,-23, and the phagocytic, and bactericidal activity of blood platelets will be determined before and after nutritional therapy.

Detailed description: Surgical treatment of gastric cancer is associated with a high risk of perioperative complications. Morbidity of cancer patients increases in concert with the clinical stage of the malignancy. It is postulated that a reduction in perioperative morbidity and improved quality of life of patients with advanced gastric cancer can be achieved by proper preparation to surgery, among others. One of such methods is the implementation of immunostimulating nutritional therapy during the perioperative period.The stage of cancer will be graded according to TNM classification. The patients will be randomly assigned to four clinical groups based on the type of nutritional therapy implemented.

Eligibility criteria: Inclusion Criteria:

* gastric cancer

Exclusion Criteria:

* for group III constituted gastric cancer associated with severe gastrointestinal obstruction

Primary outcomes:
measure: Phagocytic activity of blood platelets in gastric cancer patients.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Medical University of Bialystok
state: Podlaskie
Study officials:
affiliation: 2nd Department of General and Gastroenterological Surgery Medical University of Bialystok
name: Zbigniew Kamocki, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kamocki Z, Matowicka-Karna J, Gryko M, Zareba K, Kedra B, Kemona H. The effect of perioperative immunonutrition on the phagocytic activity of blood platelets in advanced gastric cancer patients. Clin Dev Immunol. 2013;2013:435672. doi: 10.1155/2013/435672. Epub 2013 Dec 1.