Clinical trial · Interventional
Reducing Inflammatory Syndrome in Surgery - Colorectal (RISIS-CR) Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha-ketoglutarate | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
| Standard care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Low inflammatory responder
- description
- Low inflammatory responder group - to receive standard care
- interventionNames
- Other: Standard care
- type
- EXPERIMENTAL
- label
- High inflammatory responder - AKG
- description
- High inflammatory responder group - to receive AKG tablets (1g a day, once a day, taken orally)
- interventionNames
- Dietary Supplement: Alpha-ketoglutarate
- type
- PLACEBO_COMPARATOR
- label
- High inflammatory responder - placebo
- description
- High inflammatory responder group - to receive placebo tablets (1g a day, once a day, taken orally)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged at least 45 years old * Undergoing elective colorectal cancer surgery * Able to give informed consent Exclusion Criteria: * Undergoing emergency colorectal cancer surgery * Unable to give informed consent * Females who are pregnant * Cognitively impaired patients
References
Publications (0)
Data not yet available