Polyp Prophylactic Properties of Polyacetylenes in Patients With Previous Polypectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Number and size of recurrent polyps found at the one-year follow up colonoscopy
研究概览
简要总结
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.
详细描述
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):
- 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)
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients allocated to "high-risk" group because of many small polyps (>4).
- •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.
结局指标
主要结局
Number and size of recurrent polyps found at the one-year follow up colonoscopy
时间窗: 1 year
The combined endpoint (number x size of recurrent polyps) after 1 year of treatment.
次要结局
- Polyp number and mean size per patient and the relation with the carrot consumption measurement(1 year)
- Compliance rate (Juice consumption level) and side effects(1 year)
- The number of polyps with low, medium, high degree of dysplasia and cancer(1 year)
- Acceptability of treatment(1 year)