Reducing Inflammatory Syndrome in Surgery - Colorectal (RISIS-CR) Trial
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Colorectal Cancer
In brief
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 facts
- Study ID
- NCT06646809
- Run by
- National University Hospital, Singapore
- People needed
- 80
- Starts
- 2024-05-09
- Expected to finish
- 2024-12-01
- Last updated by the study team
- 2024-10-17
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged at least 45 years old
- Undergoing elective colorectal cancer surgery
- Able to give informed consent
You may not qualify if…
- Undergoing emergency colorectal cancer surgery
- Unable to give informed consent
- Females who are pregnant
- Cognitively impaired patients
Where it is running
- National University Hospital — Singapore, Singapore, Singapore (enrolling)
- Ng Teng Fong General Hospital — Singapore, Singapore (enrolling)
- Sengkang General Hospital — Singapore, Singapore (enrolling)
- Singapore General Hospital — Singapore, Singapore (enrolling)
Full record on ClinicalTrials.gov
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