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

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

Min Age: 45 Years

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

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

For the most up-to-date information, visit the official listing.

Visit

NCT06646809


Related Trials