Clinical trial NCT04735939: Chronotherapy for Radiotherapy of Glioma
Official title: Chronotherapy for Radiotherapy of Glioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Determine Whether the Timing of Radiotherapy Has an Effect on Patient Outcomes
Keywords: radiotherapy, glioma, outcomes
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be divided into two groups.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Pathological or cytological diagnosis of glioma;
3. Normal liver and kidney function.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Second primary malignancy;
3. Severe lung infection;
4. with high blood pressure although treated with medication;
5. Patients with myocardial ischemia or myocardial infarction, arrhythmia (including QT interval \> 440 ms) or grade II cardiac insufficiency;
6. Arteriovenous thrombosis in 6 months prior to first administration, Such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism;
7. Serious heart, lung and bone marrow impairment;
8. History of severe hypertension or cerebral hemorrhage

Primary outcomes:
measure: survival time of glioma patients
timeFrame: 1/1/2021-31/12/2021
Secondary outcomes:
measure: KPS score of glioma patients.
timeFrame: 1/1/2021-31/12/2021
Other outcomes:
measure: cognitive function of glioma patients
timeFrame: 1/1/2021-31/12/2021
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
References: