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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

The effect of L-arginine supplementation and surgical trauma on the frequency myeloid-derived suppressor cells and T lymphocytes in tumour and blood of colorectal cancer patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61139514
Enrollment
100
Registered
2021-04-19
Start date
2018-04-30
Completion date
Unknown
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The effect of L-arg supplementation in patients undergoing surgery for colorectal cancer Cancer

Interventions

L-arginine and placebo kits are prepared and labelled with numbers randomly assigned by LLC Ethifarm (Poznan, Poland). Each kit contains 180 capsules of 0.5 g of substance. Patients are instructed to

Sponsors

Gdansk Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients with diagnosed colorectal cancer qualified to undergo radical surgical treatment

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Measured : 1. L-arg and ASS1 concentration, and ASS1 mRNA expression in tumour, intestinal mucosa, and blood measured using flow cytometry, quantitive PCR and ELISA 2. The frequency of M-MDSC and PMN-MDSC in tumour, intestinal mucosa (A2, B2), and blood measured using flow cytometry

Secondary

MeasureTime frame
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: 1. ASS1 concentration 2. The frequency of Th1 cells 3. The frequency of Th2 cells 4. The Th1/Th2 ratio 5. The frequency of Treg cells 6. The frequency of Th17 7. Th17/Treg ratio 8. CRP concentrations and its relation to the frequency of PMN-MDSC, M-MDSC and Th1, Th2 9. The frequency of PMN-MDSC in blood 10. The frequency of M-MDSC in blood

Countries

Poland

Contacts

Public ContactWieslaw Kruszewski
wieslaw.kruszewski@gumed.edu.pl+48 587260250

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026