ISRCTN - ISRCTN93128659: Colonic curcumin tissue levels in patients awaiting colorectal endoscopy or patients with colorectal cancer awaiting resection

Plain English Summary

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-curcumin-to-help-prevent-bowel-cancer

Trial website

Contact information

Type

Scientific

Primary contact

Prof William Steward

ORCID ID

Contact details

CSMM
2nd Floor
Osborne Building
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
+44 (0)116 258 7597
wps1@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00973869

Protocol/serial number

CTAAC protocol 230508, Version 3

Study information

Scientific title

A pilot study of the administration of curcumin to determine colonic curcumin tissue levels in patients awaiting colorectal endoscopy or patients with colorectal cancer awaiting resection

Acronym

CTAAC Pilot of curcumin

Study hypothesis

To assess colorectal tissue levels of curcumin in individuals who have taken 1.8 g of curcumin daily for 14 days. Patients are either from the National Colorectal Cancer Screening Programme or from those waiting resection of colorectal cancer.

Ethics approval

NRES, Northern & Yorkshire Research Ethics Committee, 29/11/2007, ref: 07/MRE03/31

Study design

Single arm non-randomised pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal cancer

Intervention

1. Endoscopy but only as part of routine screening under the National Colorectal Cancer Screening Programme
2. Resection of colorectal cancer by surgery

All patients will receive curcumin 1.8 g daily as tablets for 14 days prior to endoscopy. Patients will be contacted once, 7 days after completing curcumin, to ensure that no late effects have occurred.

Intervention type

Drug

Phase

Not Applicable

Drug names

Curcumin

Primary outcome measure

From 30 eligible patients who are compliant in taking all doses have tissue measurement of curcumin greater than or equal to 5 nMol/g tissue, assessed approximately two months after completion of the trial when the colon biopsies will be assayed in the laboratories for curcumin levels. The exact timing of assay will vary depending on the number of samples which will be batched together for assessment.

Secondary outcome measures

To assess the practicality, acceptability and safety of individuals taking 5 capsules of curcumin (2.25 g total daily dose of curcuminoids, 1.8 g curcumin) daily for 14 days, assessed at 3 weeks from entry to the study.

Overall trial start date

01/07/2009

Overall trial end date

31/12/2011

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Found to have faecal occult blood (FOB) as part of National Colorectal Cancer Screeing Programme or those awaiting resection of known colorectal cancer
2. Over 18 years of age, either sex
3. Using contraception

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. History in past year of discrete gastric or duodenal ulcer of size greater than 5 mm
2. Inability to return for follow up tests
3. Significant medical or psychiatric problems (including renal, hepatic or haematological dysfunction)
4. Use of any investigational agent within last 3 months
5. History of pelvic radiation
6. Women of child bearing age unless they agree to provide written confirmation that they are using adequate contraception

Recruitment start date

01/07/2009

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant (ref: 07/034)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location