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The Impact of Neurocognitive Function in Patients With Multiple Brain Metastases Receiving Whole Brain Radiation Therapy

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: NCT03626818
Recruitment Status : Not yet recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Guangdong Association of Clinical Trials

Brief Summary:
Brain metastases (BM), occurring in 10-30% of adult cancer patients, are an important cause of morbidity and mortality.The prognosis of patients with BM is generally poor, with a median survival time of 2-6 months. Whole-brain radiation therapy (WBRT) has been advocated as the primary treatment for metastatic brain cancer. WBRT injures small cerebral vasculature and neuropil,effects linked to imaging-defined white matter changes. However, information on the neurocognitive function(NCF) impact of WBRT in BM patients is also limited.This study aims to explore and evaluate the impact of NCF in patients with multiple brain metastases receiving WBRT.

Condition or disease
Brain Metastases

Detailed Description:
Brain metastases (BM), occurring in 10-30% of adult cancer patients, are an important cause of morbidity and mortality.The prognosis of patients with BM is generally poor, with a median survival time of 2-6 months. Whole-brain radiation therapy (WBRT) has been advocated as the primary treatment for metastatic brain cancer. WBRT injures small cerebral vasculature and neuropil,effects linked to imaging-defined white matter changes. However, information on the neurocognitive function(NCF) impact of WBRT in BM patients is also limited.This study aims to explore and evaluate the impact of NCF in patients with multiple brain metastases receiving WBRT.All patients were assessed at each visit for NCF according to the Hopkins Verbal Learning Test-Revised(HVLT-R),Mini-Mental Status Examination(MMSE) and Quality Of Life measurements(QOL,Questionnaire-QLQC30) .

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Neurocognitive Function in Patients With Multiple Brain Metastases Receiving Whole Brain Radiation Therapy
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : June 2021

Group/Cohort
NCF group
The patients have received 10 daily fractions of 3 Gy WBRT. Following WBRT treatment, subjects were assessed at each visit for NCT according to the Hopkins Verbal Learning Test-Revised(HVLT-R),Mini-Mental Status Examination(MMSE) and Quality Of Life measurements(QOL,Questionnaire-QLQC30).These tests was administered by trained and certified nurses or clinical research associates at baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until PS> 2 or intracranial tumor progression.



Primary Outcome Measures :
  1. Delayed recall deterioration rate(HVLT-R) [ Time Frame: At 6 month ]

Secondary Outcome Measures :
  1. Change in delayed recall(HVLT-R) [ Time Frame: At 6th week, 3rd, 9th, 12th month ]
  2. Change in recall(HVLT-R) [ Time Frame: At 6th week, 3rd, 6th, 9th, 12th month ]
  3. Change score(MMSE) [ Time Frame: At 6th week, 3rd, 6th, 9th, 12th month ]
  4. Change score(QLQBN20) [ Time Frame: At 6th week, 3rd, 6th, 9th, 12th month ]
  5. Intracranial progression-free survival for patients with different Graded Prognostic Assessment scores [ Time Frame: At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until Performance Status> 2 or intracranial tumor progression ]
  6. Overall survival for patients with different GPA scores [ Time Frame: At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until PS> 2 or intracranial tumor progression ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with multiple brain metastases will be referred through the department of Neurosurgery,Medical Oncology and Radiation-oncology at Guangdong General Hospital.
Criteria

Inclusion Criteria:

  1. Pathologically proven solid tumor malignancy.
  2. Brain MRI within 1 month of enrolment, at least three metastatic lesions in the brain (of which at least one had to be measurable according to Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1).
  3. Males or females aged ≥18 years, < 75 years.
  4. had an Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 to 2.
  5. A life expectancy of at least 3 months.
  6. Adequate organ function according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0
  7. Subjects did not receive other treatments such as cytotoxic drugs, radiotherapy (non-brain metastases) or surgery within 2 weeks.
  8. Patients must have ability and general health that permits completion of the study requirements and required follow up.
  9. Patients must be willing to complete NCF and QOL assessments at pre-specified time points outlined in the protocol.
  10. Signed written informed consent

Exclusion Criteria:

  1. Prior radiation therapy to the brain.
  2. Radiologically or pathologically confirmed metastases in the spinal cord or meninges.
  3. Taking sedatives and hypnotics, phenytoin, carbamazepine, rifampin, and barbiturate.
  4. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, hepatic, renal, or metabolic disease).
  5. Subjects suffered from dementia, mental illness and other serious cognitive dysfunction.

6.The patient's brain radiation dose needs to be increased. 7.Inability to comply with protocol or study procedures. 8.A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.

9.Pregnant female. 10.Breast-feeding


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): NCT03626818


Contacts
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Contact: Yi Pan, Dr. 0086-13719188887 panyiff01@163.com

Locations
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China, Guangdong
Guangdong General Hospital & Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China, 510080
Contact: Yi Pan, Dr.         
Principal Investigator: Yi Pan, Dr.         
Sponsors and Collaborators
Guangdong Association of Clinical Trials
Investigators
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Principal Investigator: Yi Pan, Dr. Guangdong Provincial People's Hospital
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Responsible Party: Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT03626818    
Other Study ID Numbers: CTONG1703
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: February 2018
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 Guangdong Association of Clinical Trials:
WBRT
NCT
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases