Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000459628
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
22/09/2005
Date last updated
22/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
5HIAA as a marker for anti-vascular activity
Scientific title
5HIAA as a marker for anti-vascular activity: change in serum 5HIAA in patients with advanced colorectal cancer receiving diclofenac or chemotherapy, and in control subjects without cancer receiving diclofenac
Secondary ID [1] 174 0
Clinical Trials New Zealand: CTNZ_04_3
Universal Trial Number (UTN)
Trial acronym
Hi5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced colorectal cancer 575 0
Control volunteers with no cancer 576 0
Condition category
Condition code
Cancer 650 650 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1:Patients with advanced colorectal cancer who receive a single dose of diclofenac

Group3: patients with advanced colorectal cancer receiving their first dose of chemotherapy
Intervention code [1] 369 0
Other interventions
Comparator / control treatment
Group 2: age matched control subjects who do not have cancer and have received a single dose of diclofenac.
Control group
Active

Outcomes
Primary outcome [1] 768 0
1. Determine if diclofenac induces a measurable rise in 5-HIAA production in patients with advanced colorectal cancer in 24hrs from administration.
Timepoint [1] 768 0
Primary outcome [2] 769 0
2. Compare the change in 5-HIAA induced by diclofenac and by chemotherapy in patients with advanced colorectal cancer in 24hrs from administration.
Timepoint [2] 769 0
Primary outcome [3] 770 0
3. Compare the change in 5-HIAA induced by diclofenac in patients with advanced colorectal cancer and in controls who do not have cancer in 24hrs from administration.
Timepoint [3] 770 0
Secondary outcome [1] 1562 0
None
Timepoint [1] 1562 0

Eligibility
Key inclusion criteria
Metastatic colorectal carcinoma; Histologically confirmed carcinoma of colon or rectum; No previous chemotherapy for metastatic disease. Prior adjuvant treatment allowed; Currently awaiting but not receiving chemotherapy; Over 18 years old; Able to give informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current use of NSAID, phenothiazine, monoamine oxidase inhibitors; History of peptic ulcer disease; Intolerance of NSAIDs; Creatinine > 0.15mmol/L; pregnancy; Severe impairment of the gastrointestinal tract that may impair absorption of Diclofenac; Platelet count <50PLUS; 10 age matched control subjects.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by telephone with confirmatory fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study is a pilot investigation of the feasibility of using measurement of serum 5-HIAA as a surrogate clinical marker for the antivascular activity of voltaren in patients with colorectal cancer. This study will also investigate if increases in 5 HIAA are observed in healthy controls following a dose of voltren, and whether chemotherapeutic agents also induce a rise.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 169 0
New Zealand
State/province [1] 169 0

Funding & Sponsors
Funding source category [1] 715 0
Charities/Societies/Foundations
Name [1] 715 0
Genesis Oncology Trust
Country [1] 715 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Trials New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 595 0
None
Name [1] 595 0
-
Address [1] 595 0
Country [1] 595 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36098 0
Address 36098 0
Country 36098 0
Phone 36098 0
Fax 36098 0
Email 36098 0
Contact person for public queries
Name 9558 0
Prof Michael Findlay
Address 9558 0
Cancer Trials New Zealand
Discipline of Oncology
Faculty of Medical and Health Sciences University of Auckland
Private Bag 92019
Auckland
Country 9558 0
New Zealand
Phone 9558 0
+ 64 9 3737599
Fax 9558 0
+64 9 3737927
Email 9558 0
mp.findlay@auckland.ac.nz
Contact person for scientific queries
Name 486 0
Dr Kate Gardener
Address 486 0
C/o Discipline of Oncology
Faculty of Medical and Health Sciences University of Auckland
Private Bag 92019
Auckland
Country 486 0
New Zealand
Phone 486 0
+64 9 3074949 pager 93:4503
Fax 486 0
+64 9 3737927
Email 486 0
KateG@adhb.govt.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.