RecruitingPhase 3NCT06646809

Reducing Inflammatory Syndrome in Surgery - Colorectal (RISIS-CR) Trial


Sponsor

National University Hospital, Singapore

Enrollment

80 participants

Start Date

May 9, 2024

Study Type

INTERVENTIONAL

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

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

The RISIS-CR trial is studying whether a specific treatment approach can reduce the body's inflammatory response during colorectal cancer surgery, which may help improve recovery and outcomes after the operation. **You may be eligible if...** - You are 45 years old or older - You are scheduled for planned (elective) colorectal cancer surgery - You are able to give informed consent **You may NOT be eligible if...** - You are having emergency colorectal cancer surgery - You are unable to give informed consent - You are pregnant - You have cognitive impairment that affects your ability to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTAlpha-ketoglutarate

Alpha-ketoglutarate supplements

DIETARY_SUPPLEMENTPlacebo

Placebo tablets

OTHERStandard care

Standard care


Locations(4)

National University Hospital

Singapore, Singapore, Singapore

Ng Teng Fong General Hospital

Singapore, Singapore

Sengkang General Hospital

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

View Full Details on ClinicalTrials.gov

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NCT06646809