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

Gastric Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01704664
• Other study ID #: 3-37878 L
• Status: Recruiting
• Phase: N/A
• Start date: March 2007
• Est. completion date: October 2022

Study information

• Verified date: March 2020
• Source: Medical University of Bialystok
• Contact: Zbigniew Kamocki, MD PhD
• Phone: +48606452246
• Email: zkamocki[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• gastric cancer

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Drug:
• glutamine
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.

Dietary Supplement:
• oral diet enriched with arginine (Cubitan)
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.

Drug:
• Perioperative parenteral immunonutrition (Dipeptiven, Omegaven)
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 ?3-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 ?3-fatty acids will be administered for five days.

Locations

Country	Name	City	State
Poland	Medical University of Bialystok	Bialystok	Podlaskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Noisakran S, Gibbons RV, Songprakhon P, Jairungsri A, Ajariyakhajorn Ch, Nisalak A, Jarman RG, Malasit P, Chokephaibulkit K, Perng GC. Detection of dengue virus in platelets isolated from dengue patients. Southeast Asian J Trop Med Public Health. 2009; 40

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phagocytic activity of blood platelets in gastric cancer patients.	Platelet count and phagocytic activity of thrombocytes will be examined twice in each patient. Blood samples for laboratory tests will be drawn prior to surgery and nutritional therapy and 12 days after the surgery. Thrombocyte count will be determined using ADVIA 120 haematological analyser. Phagocytic activity of blood platelets will be determined against Staphylococcus aureus ATCC 6538P bacterial strain. It expresses as the fraction of phagocytizing platelets and the phagocytic index. The fraction of phagocytizing platelets corresponds to the percentage of phagocyting thrombocytes per 1000 consecutive cells of this type. The phagocytic index represents the ratio of phagocytized bacteria per 100 phagocytic platelets.	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks