Physiological Effects of Altering Cancer-related Inflammation

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: Academy of Medical Sciences; Wellcome Trust
• Treatments: Aspirin; Ibuprofen

Criteria

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