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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Carrot juice from Yellowstone carrots cultivars
  • Placebo juice

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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