Pilot Study to Investigate the Physiological Effects Associated With Down-regulation of Host-tumour Inflammatory Responses in Colon Cancer
Bowel cancer is the second commonest cause of death from cancer in the UK. Of patients who
have an apparently curative operation, half unfortunately suffer disease recurrence and die
before 5 years. Clearly more research is required to improve outcomes in this condition.
Most current research focuses on antitumour strategies, however the reaction of the patient
(host) to the tumour is also important. The host inflammatory responses to the cancer are
likely to represent part of this host-tumour relationship. Inflammation plays an important
role in predicting patients who will die. Currently it is not known whether antiinflammatory
drugs have any effect on cancer related inflammation detected in the blood or in/around the
tumour.
Aims: We hope to demonstrate that tumour related inflammation in bowel cancer can be altered
using anti- inflammatory drugs. This may form the rationale for the use of antiinflammatory
drugs to improve prognosis in colorectal cancer patients undergoing surgery.
Methods: This pilot study will investigate whether simple antiinflammatory drugs can alter
markers of inflammation both in the blood and in/around the tumour. Patients having bowel
cancer surgery will be prescribed one of two anti-inflammatory drugs (aspirin 75mg once
daily or ibuprofen 400mg three times daily) for 2 to 3 weeks prior to their operation. Blood
and tumour samples before and after the treatment will be analysed.
If the study's aims are met and cancer-related inflammation can be altered prior to surgery,
then a larger scale drug trial will be proposed to demonstrate reduced cancer recurrence and
improved survival.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Klintrup-Makinen immune score
To evaluate the local inflammatory effects associated with down-regulation of the systemic inflammatory response prior to curative surgery as measured by Klintrup-Makinen immune score
Approx 4 weeks (post-treatment and surgery)
No
Campbell Roxburgh
Principal Investigator
University of Glasgow
UK: N/A - not a CTIMP
GN12SU401
NCT01786200
February 2013
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