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RECRUITINGINTERVENTIONAL

Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps

Polyp Prophylactic Properties of Polyacetylenes in Patients With Previous Polypectomy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Any type of resection for adenomas larger than 20 mm in size (endoscopically evaluated) or endoscopically resected T1 cancers. 2. Acceptance of the treatment and follow-up program. 3. Capability to understand and follow the instructions. Who Should NOT Join This Trial: 1. Patients allocated to "high-risk" group because of many small polyps (\>4). 2. Pregnancy. 3. Known relevant allergies. 4. Chronic consumption of COX (cyclooxygenase) inhibitors (Aspirin, Celecoxib, Ibuprofen, Diclofenac, Ketoprofen, Ketorolac, Indometacin, Naproxen, Piroxicam) or immunosuppressive agents (Methotrexate, Azathioprine or glucocorticoids). 5. Patients with different neoplastic disease under treatment (Chemo-/Radio-/Imunotherapy). 6. Severe comorbidity NYHA III-IV. 7. Lynch syndrome. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Any type of resection for adenomas larger than 20 mm in size (endoscopically evaluated) or endoscopically resected T1 cancers. 2. Acceptance of the treatment and follow-up program. 3. Capability to understand and follow the instructions. Exclusion Criteria: 1. Patients allocated to "high-risk" group because of many small polyps (\>4). 2. Pregnancy. 3. Known relevant allergies. 4. Chronic consumption of COX (cyclooxygenase) inhibitors (Aspirin, Celecoxib, Ibuprofen, Diclofenac, Ketoprofen, Ketorolac, Indometacin, Naproxen, Piroxicam) or immunosuppressive agents (Methotrexate, Azathioprine or glucocorticoids). 5. Patients with different neoplastic disease under treatment (Chemo-/Radio-/Imunotherapy). 6. Severe comorbidity NYHA III-IV. 7. Lynch syndrome.

Treatments Being Tested

DIETARY_SUPPLEMENT

Carrot juice from Yellowstone carrots cultivars

Consumption of 100 ml of carrot juice daily for 1 year

DIETARY_SUPPLEMENT

Placebo juice

Consumption of 100 ml of placebo juice daily for 1 year

Locations (1)

Department of Surgery, Odense University Hospital
Odense, Denmark