Colonic curcumin tissue levels in patients awaiting colorectal endoscopy or patients with colorectal cancer awaiting resectio
Not Applicable
Completed
- Conditions
- Colorectal cancerCancerMalignant neoplasm of rectosigmoid junction
- Registration Number
- ISRCTN93128659
- Lead Sponsor
- niversity Hospitals of Leicester NHS Trust (UK)
- Brief Summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23233733
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.