Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335420
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-13
Brief Title:
Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Polyp Prophylactic Properties of Polyacetylenes in Patients With Previous Polypectomy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Px7
Brief 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 diarycalendar
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
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 diarycalendar
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 11 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 5050 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
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 11 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 5050 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None