Plant Sterol INtervention for Cancer prevention (PINC)
Research type
Research Study
Full title
Randomised control cross-over trial to test how dietary plant sterols modify tumour promoting capabilities of non-tumour host cells in volunteers with elevated LDL-C
IRAS ID
260293
Contact name
James Thorne
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
1138866 , Funder's reference number - Breast Cancer UK Charity
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Several different human cell types can convert cholesterol into other molecules that act as signals through the body. Breast cancer patients with high levels of bad cholesterol (LDL-C) have increased levels of these signalling molecules in their tumours. The molecules, termed 'oxysterols' act as estrogens to promote breast cancer growth, but may also help tumours to spread and resist chemotherapy. Cholesterol is converted into oxysterols very efficiently by normal 'host' cells in the body that belong to the immune system (macrophages), that store fat (adipocytes) and provide support to tissues (fibroblasts). These normal 'host' cells are already known to help breast tumours metastasize and to resist chemotherapy, but exactly how they do this is not well understood.
Volunteers with elevated BMI and/or elevated cholesterol, but otherwise healthy will be given plant sterol yogurt drinks (as is already recommended for lowering cholesterol in people at risk of cardio-vascular disease) to consume every day for 8-weeks, or a placebo. Our previous work and the work of others has suggested that plant sterols may be suitable for several reasons: they lower circulating cholesterol and lower oxysterol levels; they prevent the enzymes that change cholesterol to oxysterols from working properly; and they prevent oxysterols from binding and activating their cellular receptors.
The host-cells will be collected by blood collection and by taking a sample of fat from the abdomen and mixed in the laboratory with cancer cells. The cancer cells will then be measured to see if their behaviour (division, movement, ability to resist chemotherapy drugs) is different before and after the plant sterol diet has been followed. This should allow us to determine if plant sterols could be a possible addition to, and improve the effectiveness of normal therapy.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0239
Date of REC Opinion
26 Jul 2019
REC opinion
Favourable Opinion