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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