Colorectal cancer Cancer Malignant neoplasm of other and ill-defined digestive organs
Conditions
Interventions
Colonic mucosal biopsies from tumour and normal mucosa will be obtained from all consented volunteers at the time of endoscopy. Then they will be randomised into two groups, one group will get resista
Sponsors
Northumbria Healthcare NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All individuals who are found to have a colorectal lesion suspicious of malignancy which would require an elective operation at the time of colonoscopy/flexible sigmoidoscopy. About 10%-12% of all sporadic colorectal cancers have defective MLH1 gene (Lothe RA, Cancer Res 1993). By recruiting all sporadic colorectal cancer patients we will have recruited individuals both with and without loss of function of the MLH1 gene and hence, we will be able test our hypothesis that the MLH1 gene influences response to Resistant Starch.
Exclusion criteria
Exclusion criteria: 1. Patients who have had a subtotal colectomy with an ileorectal anastamosis (insufficient length of functioning large bowel for the resistant starch to have effect) 2. Patients with ileostomy or a diversion colostomy (resistant starch will not reach the colonic lumen) 3. Individuals who are not capable of giving their informed consent 4. Individuals who cannot continue taking the oral supplements for any reason 5. Pregnant women (effect of resistant starch in pregnant women and foetuses has not yet not evaluated)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in gene expression, cell proliferation and apoptosis in the pre treatment and post treatment samples and in patients with and without a functioning MLH1 gene. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed