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Chronotherapy for Radiotherapy of Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04735939
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University

Study Description
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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.

Condition or disease Intervention/treatment
To Determine Whether the Timing of Radiotherapy Has an Effect on Patient Outcomes 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 Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronotherapy for Radiotherapy of Glioma
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. survival time of glioma patients [ Time Frame: 1/1/2021-31/12/2021 ]
    Determine whether morning vs. evening dosing radiotherapy could affect the survival time of glioma patients.


Secondary Outcome Measures :
  1. KPS score of glioma patients. [ Time Frame: 1/1/2021-31/12/2021 ]
    Determine whether morning vs. evening dosing radiotherapy could affect the KPS score of glioma patients.


Other Outcome Measures:
  1. cognitive function of glioma patients [ Time Frame: 1/1/2021-31/12/2021 ]
    Determine whether morning vs. evening dosing radiotherapy could affect the cognitive function of glioma patients.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients will be divided into two groups.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735939


Contacts
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Contact: Hechun Xia, bachelor 86-951-6743983 xhechun@aliyun.com

Locations
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China, Ningxia
General Hospital of Ningxia Medical University Recruiting
Yinchuan, Ningxia, China, 750004
Contact: Jie Wei, M.D.    86-951-6744528    nyfykyc@163.com   
Sponsors and Collaborators
General Hospital of Ningxia Medical University
More Information
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Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT04735939    
Other Study ID Numbers: xhechun5
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by General Hospital of Ningxia Medical University:
radiotherapy, glioma, outcomes
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue