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
- 1
- 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.
研究组 & 干预措施
Carrot juice
The cultivation of "Yellowstone" carrots will be conducted by DanRoots A/S.DanRoots, Organic Vegetables, Bjerringbro, Denmark.Juice is produced and taste corrected by Orskov Food, Denmark in collaboration with Naturfrisk, Ørbæk.
Analysis of carrot juice for falcarinol and falcarindiol content will be done at random from 10 samples leaving the factory and 10 samples collected after 30 days storage at participant's homes for each batch.
干预措施: Carrot juice from Yellowstone carrots cultivars (Dietary Supplement)
Placebo juice
Placebo juice is produced from natural flavours and taste corrected by Orskov Food, Denmark in collaboration with Naturfrisk, Ørbæk. The taste is corrected to prevent enabling differentiation between carrot juice and placebo.
干预措施: Placebo juice (Dietary Supplement)
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)