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Pilot Study to Investigate the Physiological Effects Associated With Down-regulation of Host-tumour Inflammatory Responses in Colon Cancer

18 Years
75 Years
Not Enrolling
Colon Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Klintrup-Makinen immune score

Outcome Description:

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

Outcome Time Frame:

Approx 4 weeks (post-treatment and surgery)

Safety Issue:


Principal Investigator

Campbell Roxburgh

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Glasgow


UK: N/A - not a CTIMP

Study ID:




Start Date:

February 2013

Completion Date:

Related Keywords:

  • Colon Cancer
  • colon
  • cancer
  • inflammation
  • Colonic Neoplasms
  • Inflammation