The goal of this prospective randomized double-blinded bi-national study is to test the prophylactic effect of polyacetylenes from carrots on the population of patients who had a resection of high-risk adenomas of the large bowel.
The main question it aims to answer is: Will carrot juice rich in polyacetylenes inhibit neoplastic transformation and growth in high-risk humans?
Participants will have to drink 100 ml of juice daily after the adenoma resection for 1 year and keep a simple diary/calendar.
Researchers will compare the group with ingestion of Falcarinol (FaOH) / Falcarindiol (FaDOH) rich carrot juice versus the group consuming placebo juice, to see if the polyacetylenes significantly reduces neoplastic transformation and growth in high-risk patients.
Any type of resection for adenomas larger than 20 mm in size (endoscopically evaluated) or endoscopically resected T1 cancers.
Acceptance of the treatment and follow-up program.
Capability to understand and follow the instructions.
Patients allocated to "high-risk" group because of many small polyps (>4).
Pregnancy.
Known relevant allergies.
Chronic consumption of COX (cyclooxygenase) inhibitors (Aspirin, Celecoxib, Ibuprofen, Diclofenac, Ketoprofen, Ketorolac, Indometacin, Naproxen, Piroxicam) or immunosuppressive agents (Methotrexate, Azathioprine or glucocorticoids).
Parallel
Carrot juice from Yellowstone carrots cultivars
Dietary supplementConsumption of 100 ml of carrot juice daily for 1 year
Placebo juice
Dietary supplementConsumption of 100 ml of placebo juice daily for 1 year
Number and size of recurrent polyps found at the one-year follow up colonoscopy
The combined endpoint (number x size of recurrent polyps) after 1 year of treatment.
Polyp number and mean size per patient and the relation with the carrot consumption measurement
A covariate analysis of carrot consumption (concentration of polyacetylenes exposure) measured through diaries, calendar and questionnaires and the findings at the 1 year colonoscopy (number of polyps multiplied by mean diameter of adenomas per patient).
Compliance rate (Juice consumption level) and side effects
Assessment of compliance rate and side effects through diary, calendar marks and questionnaire
The number of polyps with low, medium, high degree of dysplasia and cancer
Assessment of polyps through endoscopy and pathology reports
Acceptability of treatment
Assessment of acceptance and ways to improve carrot products through diary and questionnaire
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Odense University Hospital
Lead sponsor
Karolinska Institutet
Collaborator
Umeå University
Collaborator
Uppsala University Hospital
Collaborator
Svendborg Hospital
Collaborator
Ersta Hospital, Sweden
Collaborator
St Goran's Hospital
Collaborator
Sahlgrenska University Hospital
Collaborator
