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Trial Title:
Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps
NCT ID:
NCT06335420
Condition:
Colorectal Cancer Prevention
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Carrot juice from Yellowstone carrots cultivars
Description:
Consumption of 100 ml of carrot juice daily for 1 year
Arm group label:
Carrot juice
Intervention type:
Dietary Supplement
Intervention name:
Placebo juice
Description:
Consumption of 100 ml of placebo juice daily for 1 year
Arm group label:
Placebo juice
Summary:
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.
Detailed description:
The study is a prospective double-blinded randomized controlled trial carried out in four
centers: one Danish (Department of Surgery, Odense University Hospital - OUH) and five
Swedish (Ersta Hospital - EH, Stockholm; Karolinska University Hospital - KUH, Stockholm;
Uppsala University Hospital - UUH, Uppsala; Sahlgrenska University Hospital - SUH,
Goteborg, Capio St. Gorans Hospital - CSH, Stockholm).
The investigators will organize two parallel arms of 400 patients: an intervention arm
(consumption of 100 ml active carrot juice daily) and a control arm (consumption of 100
ml placebo juice daily) in a 1:1 randomized allocation ratio for 1 year. The project is
structured in 2 working packages (WP):
1. The clinical trial (including cultivation and quality control of carrots and juice
production; quantification of FaOH and FaDOH in the carrot and the placebo juice and
the randomized trial)
2. The assessment of patient compliance and ways to improve it (Umeå Institute of
Design, Umeå University - UMU).
The investigators hypothesize that the difference between the active arm (carrot juice)
and the control arm (placebo juice) measured by number and growth rate (size) of
recurrent adenomas will mediate a 20% reduction or larger in both size and number.
Outcomes will be investigated through standard colonoscopy report, questionnaires,
calendars and diaries.
The randomization is stratified by inclusion center, each having its own block of 50/50
distribution between active and placebo arm.
The patients will collect 8 L of juice, the diary, calendar and a questionnaire every 2
months. At this meeting the patients will also have a follow-up discussion with the
project nurse.
All patients will undergo colonoscopy after one year from the resection and in addition,
for the piecemeal resections there will also be a local follow up colonoscopy after 6
months. Information about recurrence, the number of polyps, polyp size and
characterization will be registered in the database. Full compliance is defined as
consumption of > 75% of the juice delivered. Consumption data for all patients will be
kept for compliance analysis.
Data will be analyzed using exact methods for binomial data. The combined endpoint will
be the total number of recurrent adenomas multiplied with mean size of recurrent adenomas
in the relevant treatment group.
Participation is voluntary with no economic compensation, and the patients are informed
orally and in writing according to the information accepted by the ethics committee.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Any type of resection for adenomas larger than 20 mm in size (endoscopically
evaluated).
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. Severe comorbidity NYHA III-IV.
6. Lynch syndrome.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Surgery, Odense University Hospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Alexandra Agache, postdoc researcher
Phone:
+4520355717
Email:
Alexandra.Agache@rsyd.dk
Contact backup:
Last name:
Camilla Stryhn, Project Manager
Phone:
+4523612333
Email:
camilla.stryhn@rsyd.dk
Investigator:
Last name:
Michael B Mortensen, MD, Ph.D.
Email:
Principal Investigator
Investigator:
Last name:
Gunnar Baatrup, MD, Ph.D.
Email:
Principal Investigator
Start date:
June 20, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Odense University Hospital
Agency class:
Other
Collaborator:
Agency:
Karolinska Institutet
Agency class:
Other
Collaborator:
Agency:
Umeå University
Agency class:
Other
Collaborator:
Agency:
Uppsala University Hospital
Agency class:
Other
Collaborator:
Agency:
Svendborg Hospital
Agency class:
Other
Collaborator:
Agency:
Ersta Hospital, Sweden
Agency class:
Other
Collaborator:
Agency:
St Goran's Hospital
Agency class:
Other
Collaborator:
Agency:
Sahlgrenska University Hospital, Sweden
Agency class:
Other
Source:
Odense University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06335420
