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

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

NCT ID: NCT01704664

Condition: Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms

Conditions: Keywords:
malnutrition,
perioperative artificial nutrition,
immunonutrition,
gastrectomy,
lymphocytes,
interleukin,
blood platelets,
phagocytic and bactericidal activity of blood platelets

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Dietary Supplement
Intervention name: Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb)
Description: Early postoperative enteral nutrition with standard elementary diet (Peptisorb), will start 20 hours post-surgery. The initial flow rate will be 8 ml/h, which will increase gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition wil 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).
Arm group label: I - Nutritional therapy only during the postoperative period.
Arm group label: II - parenteral glutamine in postoperative time
Arm group label: IV - Perioperative parenteral immunonutrition

Intervention type: Drug
Intervention name: glutamine
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.
Arm group label: II - parenteral glutamine in postoperative time

Intervention type: Dietary Supplement
Intervention name: oral diet enriched with arginine (Cubitan)
Description: Preoperatively, group III patients will be given commercially available oral diet enriched with arginine (Cubitan, 1 package 3 times per day). Additionally, they were 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 increase 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.
Arm group label: III - perioperative oral immunonutrition

Intervention type: Drug
Intervention name: Perioperative parenteral immunonutrition (Dipeptiven, Omegaven)
Description: Nutritional therapy of group IV will based on intravenous preparations. Two-chamber bags with 480 kcal energetic value and 5.7 g of N in standard amino acids were 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 start 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 was 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.
Arm group label: IV - Perioperative parenteral immunonutrition

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - gastric cancer Exclusion Criteria: - for group III constituted gastric cancer associated with severe gastrointestinal obstruction

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Medical University of Bialystok

Address:
City: Bialystok
Zip: 15089
Country: Poland

Status: Recruiting

Contact:
Last name: Zbigniew Kamocki, MD PhD

Phone: +48606452246
Email: zkamocki@gmail.com

Investigator:
Last name: Zbigniew Kamocki, MD PhD
Email: Principal Investigator

Investigator:
Last name: Joanna Matowicka-Karna, MD PhD
Email: Sub-Investigator

Investigator:
Last name: Joanna Osada, MD PhD
Email: Sub-Investigator

Start date: March 2007

Completion date: October 2022

Lead sponsor:
Agency: Medical University of Bialystok
Agency class: Other

Source: Medical University of Bialystok

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01704664