Clinical trial · Interventional
Physiological Effects of Altering Cancer-related Inflammation
Pilot Study to Investigate the Physiological Effects Associated With Down-regulation of Host-tumour Inflammatory Responses in Colon Cancer
NCT01786200CI-TRIAL-00009359unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This prospective pilot study will examine whether the previously reported effects of NSAIDs on colorectal cancer may be modulated through alterations in tissue gene expression, up regulation of local immune cell infiltrates or down-regulation of the systemic inflammatory response.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Aspirin
- description
- 20 patients randomised to aspirin 75mg PO once daily
- interventionNames
- Drug: Aspirin
- type
- ACTIVE_COMPARATOR
- label
- Ibuprofen
- description
- 20 patients randomised to ibuprofen 400mg PO three times daily
- interventionNames
- Drug: Ibuprofen
- type
- NO_INTERVENTION
- label
- Control
- description
- 20 patients randomised to receive no treatment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * aged 18 to 75 years old * histologically confirmed colon cancer * evidence of systemic inflammation (C-reactive protein \>10mg/l) * candidate for elective primary curative resection Exclusion Criteria: * Age \<18yrs or \>75yrs * emergency presentation * rectal cancer * distal metastatic disease at presentation * provision of neo-adjuvant chemo-radiotherapy * long-term use of aspirin or anti-inflammatory medications (NSAIDS, or steroids * hypersensitivity to product or excipients or evidence of previous hypersensitivity reactions such as asthma, rhinitis, angioedema or urticaria in response to aspirin, ibuprofen or other NSAID * intolerance of NSAIDs/ aspirin due to allergy or side effects * active peptic ulcer disease * previous history of recurrent gastrointestinal bleeding or bleeding/perforation secondary to previous NSAID use * previous treatment for gastrointestinal cancer * alcohol excess (above recommended guidelines) * chronic renal impairment * moderate to severe heart failure * hepatic impairment
References
Publications (0)
Data not yet available
No reference posted for this study.