Study Intestinal Complaints During Chemotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- 1. How common are constipation symptoms in patients undergoing chemotherapy treatment?
研究概览
简要总结
Study intestinal complaints during chemotherapy. A prospective study into intestinal complaints in patients undergoing chemotherapy treatment. A pre and post implementation design is used to establish if eating two kiwi fruits per day can prevent constipation.
详细描述
The Medical Research Involving Human Subjects Act (WMO) does not apply to this research. Nonetheless it will be conducted according to the principals of Good Clinical Practice (GCP), privacy legislation (AVG) and Medical Treatment Agreement Act (WGBO). The consumption of eating two kiwi's a day can be seen as a slight variation on standard advice with regards to a healthy diet. Maintaining a diary may take some time from the participant but at the same time is of use during follow up visits where side effects, including the occurrence of constipation are discussed. The The study is approved by the Advisory Committee on Local Feasibility (ACLU) of the Spaarne Gasthuis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •First chemotherapy/cytostatics treatment
- •Neo-adjuvant or adjuvant treatment
- •Performance status World Health Organization (WHO) 0-1
- •Written informed consent
- •Command of the Dutch language
排除标准
- •Kiwi allergy
- •Patients using standard laxatives prior to the first chemotherapy/cytostatic treatment.
- •Patients with a history of bowel resection
- •Patients with stoma
结局指标
主要结局
1. How common are constipation symptoms in patients undergoing chemotherapy treatment?
时间窗: 1 year
次要结局
- 2. Does the use of laxatives decrease when consuming two kiwi's a day?(1 year)
- 3. Which interventions against constipation do patients experience as the most comfortable?(1 year)