Chronotherapy for Radiotherapy of Glioma

NCT04735939 | Unknown

• 1 other identifier: xhechun5
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

radiotherapy, glioma, outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• KPS score of glioma patients.

  1/1/2021-31/12/2021

Other Outcomes (1)

• cognitive function of glioma patients

  1/1/2021-31/12/2021

Study Arms (2)

morning dosing radiotherapy

Radiation: radiotherapy

evening dosing radiotherapy

Radiation: radiotherapy

Interventions

radiotherapy 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; morning dosing radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will be divided into two groups.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Hechun Xia, bachelor

CONTACT

86-951-6743983; xhechun@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)