Chronotherapy for Radiotherapy of Glioma

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.

Study Overview

• Status: Recruiting
• Conditions: To Determine Whether the Timing of Radiotherapy Has an Effect on Patient Outcomes
• Intervention / Treatment: Radiation: radiotherapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Hechun Xia, bachelor; Phone Number: 86-951-6743983; Email: xhechun@aliyun.com

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Jie Wei, M.D.; Phone Number: 86-951-6744528; Email: nyfykyc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients will be divided into two groups.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
morning dosing radiotherapy	Radiation: 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.
evening dosing radiotherapy	Radiation: 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.

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: radiotherapy, glioma, outcomes
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: xhechun5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No