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

NCT06646809 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-10-17

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Alpha-ketoglutarate

Alpha-ketoglutarate supplements

DIETARY_SUPPLEMENT

Placebo

Placebo tablets

OTHER

Standard care

Standard care

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Lian Kah Ti · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-09
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06646809 on ClinicalTrials.gov