Chronotherapy for Radiotherapy of Glioma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Chronotherapy for Radiotherapy of Glioma

Conditions
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To Determine Whether the Timing of Radiotherapy Has an Effect on Patient Outcomes

Intervention / Treatment
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* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Pathological or cytological diagnosis of glioma; Normal liver and kidney function. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| morning dosing radiotherapy<br> | Radiation: radiotherapy<br>* 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.<br>|
| evening dosing radiotherapy<br> | Radiation: radiotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival time of glioma patients | Determine whether morning vs. evening dosing radiotherapy could affect the survival time of glioma patients. | 1/1/2021-31/12/2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KPS score of glioma patients. | Determine whether morning vs. evening dosing radiotherapy could affect the KPS score of glioma patients. | 1/1/2021-31/12/2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, glioma, outcomes