Towards Optimal Personalized Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- the change in the proportion of patients with normal vitamin values
研究概览
简要总结
This study aims to investigate if the proportion of neuroendocrine tumor (NET) patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet, Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.
详细描述
Objective
This study aims to investigate if the proportion of NET patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet.
Methods:
This is a single center 18-week open-label, non-comparative, single-arm, intervention study. After inclusion and the first measurements, adult patients with metastasized or irresectable NET will continue with four weeks of standard treatment. After these four weeks participants with vitamin values below normal will get vitamin suppletion for each deficient vitamin and all participants will get the dietary intervention during 14 weeks. Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, including; baseline characteristics, quantitative analysis of blood and urine and questionnaires will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patients aged ≥ 18 years
- •NET-patients with serotonin producing or non-serotonin producing tumors, with gastro-intestinal, pancreatic, bronchopulmonary or unknown primary tumor site and with metastasized or irresectable disease
- •Ability to comprehend Dutch (both reading and writing).
- •Written informed consent provided.
- •Use of somatostatin analogue for > 6 months.
排除标准
- •Estimated life expectancy less than 6 months.
- •Patients who have a history of another primary malignancy, except for radical and adequately treated malignancies from which the patient has been disease free for ≥ 1 year.
- •Major abdominal surgery during study period.
- •Patients already participated in the DIVIT-pilot study
- •Known hypersensitivity of (components of) somatostatin analogue
结局指标
主要结局
the change in the proportion of patients with normal vitamin values
时间窗: 18 weeks
the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine
次要结局
- difference in the self-reported healthy eating pattern.(18 weeks)
- nutrition state(18 weeks)
- change in quality of life(18 weeks)
- distress(18 weeks)
- problems(18 weeks)