Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps
Recruiting · NCT06335420 · Interventional (participants receive a specific treatment) · Lead sponsor: Odense University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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).
- Patients with different neoplastic disease under treatment (Chemo-/Radio-/Imunotherapy).
- Severe comorbidity NYHA III-IV.
- Lynch syndrome.
Where it is running
1 location listed.
- Department of Surgery, Odense University Hospital - Odense, Denmark