The effect of supplementation with an amino acid that helps the body build protein (L-arginine) on change in the immune system of colorectal cancer patients
Not Applicable
Completed
- Conditions
- The effect of L-arg supplementation in patients undergoing surgery for colorectal cancerCancer
- Registration Number
- ISRCTN61139514
- Lead Sponsor
- Gdansk Medical University
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/34995935/ (added 12/01/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 65
Inclusion Criteria
Adult patients with diagnosed colorectal cancer qualified to undergo radical surgical treatment
Exclusion Criteria
1. Chemotherapy and/or radiotherapy in the last 5 years
2. Autoimmune diseases
3. Liver or kidney failure
4. Uncontrolled diabetes
5. Acute and chronic inflammatory diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Measured :<br> 1. L-arg and ASS1 concentration, and ASS1 mRNA expression in tumour, intestinal mucosa, and blood measured using flow cytometry, quantitive PCR and ELISA<br> 2. The frequency of M-MDSC and PMN-MDSC in tumour, intestinal mucosa (A2, B2), and blood measured using flow cytometry<br>
- Secondary Outcome Measures
Name Time Method <br> Blood parameters measured using flow cytometry and ELISA before supplementation; one day after the end of supplementation - immediately before the surgery; and one day after the surgery:<br> 1. ASS1 concentration<br> 2. The frequency of Th1 cells<br> 3. The frequency of Th2 cells<br> 4. The Th1/Th2 ratio<br> 5. The frequency of Treg cells<br> 6. The frequency of Th17<br> 7. Th17/Treg ratio<br> 8. CRP concentrations and its relation to the frequency of PMN-MDSC, M-MDSC and Th1, Th2<br> 9. The frequency of PMN-MDSC in blood<br> 10. The frequency of M-MDSC in blood<br>