Chronotherapy for Radiotherapy of Glioma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- survival time of glioma patients
研究概览
简要总结
This study aims to determine if there is any difference in the efficacy of radiotherapy for glioma outcomes in the morning or in the evening. The study team believes that there may be a benefit to taking the radiotherapy at a certain time of day. To test this theory the study asks participants who are already taking radiotherapy for glioma consistently at either the morning or in the evening based on when they currently take their radiotherapy. There will be this study visits where the participant will be asked to fill in questionnaires related to their neurological symptoms, their sleep habits, sleep quality, survival situation, and general health information followed by a blood draw.
详细描述
The objective of this study is to determine whether the timing of radiotherapy to treat glioma has an effect on patient outcomes.
Primary objective: Determine whether there is a difference in outcomes seen when patients are assigned to take their radiotherapy at either a morning time or evening time.
The Investigator hypothesize that administration time of radiotherapy during the day can affect the clinical outcomes in glioma patients.
Specific Aims Include:
- Determine whether morning vs. evening dosing radiotherapy could affect the survival time of glioma patients.
- Determine whether morning vs. evening dosing radiotherapy could affect the KPS score of glioma patients.
- Determine whether morning vs. evening dosing radiotherapy could affect the cognitive function of glioma patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Pathological or cytological diagnosis of glioma;
- •Normal liver and kidney function.
排除标准
- •Pregnant or lactating women;
- •Second primary malignancy;
- •Severe lung infection;
- •with high blood pressure although treated with medication;
- •Patients with myocardial ischemia or myocardial infarction, arrhythmia (including QT interval > 440 ms) or grade II cardiac insufficiency;
- •Arteriovenous thrombosis in 6 months prior to first administration, Such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism;
- •Serious heart, lung and bone marrow impairment;
- •History of severe hypertension or cerebral hemorrhage
结局指标
主要结局
survival time of glioma patients
时间窗: 1/1/2021-31/12/2021
Determine whether morning vs. evening dosing radiotherapy could affect the survival time of glioma patients.
次要结局
- KPS score of glioma patients.(1/1/2021-31/12/2021)