PROstate CAncer Radiotherapy: Its Real Impact on Bowel Symptoms & Quality of Life Today, Measured by the EORTC QLQ C30 & Specific PRT20 Module.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Mean Delta of EORTC Proctitis Module (PRT20) score
研究概览
简要总结
This is a prospective pilot study to evaluate the mean increase of bowel symptoms after pelvic radiotherapy (RT) in prostate cancer (PCa) patient using the validated & newly translated EORTC-QLQ PRT20 module.
详细描述
Questionnaires (QLQ-C30 and PRT20 modules) will be held to patients at the beginning and at the end of RT (4 weeks) to evaluate the mean increase of lower GI symptoms and decrease in overall QoL after pelvic RT.
For exploratory objectives, GLIM (Global Leadership Initiative on Malnutrition) criteria for malnutrition diagnosis, a 24h recall and DQI-I calculation will be assessed by the PI before the start of RT. CT sim & dosimetry will be analyse by the PI before treatment to evaluation the body composition and the max and mean dose received by the bowel, the sigmoid and the rectum. A Polar watches will be loaned to the patient by the PI at the CT sim appointment to record patient's daily movement for two weeks (usual waiting time between CT and treatment) and recovered on the first day of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with PCa which are candidate for pelvic radiotherapy (RT) with or without previous surgery, with or without concomitant hormonotherapy (HT), Performance status (PS) 0-2 (all patient able to undergo RT treatment), of all age, elderly included.
排除标准
- •Previous RT to the pelvis
- •Diagnosed Inflammatory Bowel Disease (IBD), celiac disease
- •Severe GI symptoms before the beginning of RT (Grade > 2 according to CTCAE grading system)
- •Obvious cognitive impairment,
- •Inability to understand French/English and no contact person able to accompany and translate.
结局指标
主要结局
Mean Delta of EORTC Proctitis Module (PRT20) score
时间窗: At study completion, an average of 4 months
Mean Delta between the end and the beginning of RT (4 weeks) in PRT20 score (Min 18, Max 72, higher scores mean worse outcome)
次要结局
- Mean Delta of EORTC Quality of Life Questionnaire (QLQ-C30) score(At study completion, an average of 4 months)
研究者
Pauline De Bruyn
Principal Investigator
Jules Bordet Institute