Reducing Inflammatory Syndrome in Surgery - Colorectal (RISIS-CR) Trial
National University Hospital, Singapore
80 participants
May 9, 2024
INTERVENTIONAL
Conditions
Summary
The study proposes to identify inflammatory responsiveness of patients prior to CRC surgery and administer prophylactic anti-inflammatory treatment targeted only to those with an excessive pro-inflammatory response. The study team believe this to be a creative approach as the principles of personalized medicine will be used to treat the appropriate patients, and equally as importantly, to not further suppress the inflammatory response of those who have poor immune function already. Geroprotectors reduce inflammation, and may reduce postoperative SIR and complications after CRC surgery. In this proposal, we intend to use alpha ketoglutarate (AKG), a geroprotector supplement that enjoys a GRAS (generally regarded as safe) status with the FDA. \[12\] Apart from reducing inflammation and inhibiting the mTOR pathway, AKG also prevents loss of muscle mass, improves brain oxygenation, has cardioprotective effects, and improves renal function. It also has anti-cancer effects beyond mTOR pathway inhibition, including regulating HIF-1 activity, suppressing secretion of angiogenic factors, and regulating epigenetic processes.
Eligibility
Inclusion Criteria3
- Patients aged at least 45 years old
- Undergoing elective colorectal cancer surgery
- Able to give informed consent
Exclusion Criteria4
- Undergoing emergency colorectal cancer surgery
- Unable to give informed consent
- Females who are pregnant
- Cognitively impaired patients
Interventions
Alpha-ketoglutarate supplements
Placebo tablets
Standard care
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06646809