Colonic curcumin tissue levels in patients awaiting colorectal endoscopy or patients with colorectal cancer awaiting resection
| ISRCTN | ISRCTN93128659 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93128659 |
| ClinicalTrials.gov number | NCT00973869 |
| Secondary identifying numbers | CTAAC protocol 230508, Version 3 |
- Submission date
- 29/05/2009
- Registration date
- 19/08/2009
- Last edited
- 26/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof William Steward
Scientific
Scientific
CSMM
2nd Floor
Osborne Building
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
| Phone | +44 (0)116 258 7597 |
|---|---|
| wps1@le.ac.uk |
Study information
| Study design | Single arm non-randomised pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | CTAAC Pilot of curcumin |
| Study objectives | 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(s) | NRES, Northern & Yorkshire Research Ethics Committee, 29/11/2007, ref: 07/MRE03/31 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/2009 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2009 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
LE1 5WW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Professor David Rowbotham
Director of Research and Development
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4QF
England
United Kingdom
| Phone | +44 (0)116 258 4199 |
|---|---|
| djr8@le.ac.uk | |
| Website | http://www.uhl-tr.nhs.uk/ |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant (ref: 07/034)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/02/2013 | Yes | No |
Editorial Notes
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
