Perioperative Immunonutrition, Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients

Medical University of Bialystok

Status: Unknown

Conditions: Gastric Cancer

Treatments: Dietary Supplement: Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb); Drug: Perioperative parenteral immunonutrition (Dipeptiven, Omegaven); Dietary Supplement: oral diet enriched with arginine (Cubitan); Drug: glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01704664

3-37878 L

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gastric cancer

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

I - Nutritional therapy only during the postoperative period.

Active Comparator group

Description:

Postoperative nutritional therapy administered in group I will not include immunomodulating factors. Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb), starts 20 hours post-surgery. The initial flow rate will be 8 ml/h, which will be increased gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition will be continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins (commercially available two-chamber bag for peripheral access with 480 kcal of energetic value and 5.7g of N contained in standard amino acids).

Treatment:

Dietary Supplement: Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb)

II - parenteral glutamine in postoperative time

Active Comparator group

Description:

The nutritional therapy of group II patients will start post-surgery. It will be based on early enteral nutrition with elementary diet (Peptisorb) with simultaneous parenteral nutrition with two-chamber bag with 480 kcal energetic value and 5.7g of N contained in standard amino acids administered via peripheral veins. Additionally, glutamine (100 ml of Dipeptiven) will be added to the two-chamber bag. The parenteral nutrition will be administered for five days.

Treatment:

Drug: glutamine

Dietary Supplement: Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb)

III - perioperative oral immunonutrition

Active Comparator group

Description:

Preoperatively, group III patients will be given commercially available oral diet enriched with arginine (Cubitan, 1 package 3 times per day). Additionally, they will be administered commercially available two-chamber bag with 480 kcal energetic value and 5.7g of N in standard amino acids via peripheral access. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with commercially available arginine-containing diet (Cubison) will start 20 hours post-surgery at an 8 ml/h flow rate; the rate will be increased gradually, with the volume doubled every 24 hours, up to 100 ml/h and continued for six days. Simultaneously, commercially available two-chamber bags for peripheral access with composition identical to that used preoperatively will be administered via peripheral veins for five days.

Treatment:

Dietary Supplement: oral diet enriched with arginine (Cubitan)

IV - Perioperative parenteral immunonutrition

Active Comparator group

Description:

Nutritional therapy of group IV will be based on intravenous preparations. Two-chamber bags with 480 kcal energetic value and 5.7 g of N in standard amino acids will be administered preoperatively. A solution of glutamine (Dipeptiven, 100 ml) and ω3-fatty acids (Omegaven, 100 ml) will be added to the bags. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with elementary commercially available diet (Peptisorb) will be begun 20 hours post-surgery; it will be started at an 8 ml/h flow rate and increased gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition will be continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins; similarly to the preoperative period, the content of two-chamber bag for peripheral access enriched with glutamine and ω3-fatty acids will be administered for five days.

Treatment:

Drug: Perioperative parenteral immunonutrition (Dipeptiven, Omegaven)

Dietary Supplement: Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb)