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RECRUITING
NCT06646809
PHASE3

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

Sponsor: National University Hospital, Singapore

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-05-09

Completion Date

2024-12

Last Updated

2024-10-17

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Alpha-ketoglutarate

Alpha-ketoglutarate supplements

DIETARY_SUPPLEMENT

Placebo

Placebo tablets

OTHER

Standard 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