NCT01786200

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

January 29, 2013

Last Update Submit

February 5, 2013

Conditions

Colon Cancer

Keywords

coloncancerNSAIDinflammation

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • Systemic inflammatory response

    Approx 4 weeks (post-treatment and surgery)

  • Assessment of gene inflammatory profile

    Approx 4 weeks (post-treatment and surgery)

  • Local inflammatory response

    Approx 4 weeks (post-treatment and surgery)

Study Arms (3)

Aspirin

ACTIVE COMPARATOR

20 patients randomised to aspirin 75mg PO once daily

Drug: Aspirin

Ibuprofen

ACTIVE COMPARATOR

20 patients randomised to ibuprofen 400mg PO three times daily

Drug: Ibuprofen

Control

NO INTERVENTION

20 patients randomised to receive no treatment

Interventions

AspirinDRUG
Aspirin
IbuprofenDRUG
Ibuprofen

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Royal Infirmary - Walton Building

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Colonic NeoplasmsNeoplasmsInflammation

Interventions

AspirinIbuprofen

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Campbell Roxburgh

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Park

CONTACT

0141 211 4870james.park@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 7, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

GB(1)