Chronotherapy for Radiotherapy of Glioma

NCT ID: NCT04735939

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

morning dosing radiotherapy

radiotherapy

Intervention Type: RADIATION

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.

evening dosing radiotherapy

radiotherapy

Intervention Type: RADIATION

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.

Interventions

radiotherapy

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hechun Xia, bachelor

Role: CONTACT

xhechun@aliyun.com

86-951-6743983

Facility Contacts

Jie Wei, M.D.

Role: primary

nyfykyc@163.com

86-951-6744528

Other Identifiers

xhechun5

Identifier Type: -

Identifier Source: org_study_id