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

NCT03626818 | Unknown

• 1 other identifier: CTONG1703
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases

Keywords

WBRT; NCT

Outcome Measures

Primary Outcomes (1)

• Delayed recall deterioration rate(HVLT-R)

  At 6 month

Secondary Outcomes (6)

• Change in delayed recall(HVLT-R)

  At 6th week, 3rd, 9th, 12th month

• Change in recall(HVLT-R)

  At 6th week, 3rd, 6th, 9th, 12th month

• Change score(MMSE)

  At 6th week, 3rd, 6th, 9th, 12th month

• Change score(QLQBN20)

  At 6th week, 3rd, 6th, 9th, 12th month

• Intracranial progression-free survival for patients with different Graded Prognostic Assessment scores

  At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until Performance Status> 2 or intracranial tumor progression

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pathologically proven solid tumor malignancy.
• 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).
• Males or females aged ≥18 years, \< 75 years.
• had an Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 to 2.
• A life expectancy of at least 3 months.
• Adequate organ function according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0
• Subjects did not receive other treatments such as cytotoxic drugs, radiotherapy (non-brain metastases) or surgery within 2 weeks.
• Patients must have ability and general health that permits completion of the study requirements and required follow up.
• Patients must be willing to complete NCF and QOL assessments at pre-specified time points outlined in the protocol.
• Signed written informed consent

You may not qualify if:

• Prior radiation therapy to the brain.
• Radiologically or pathologically confirmed metastases in the spinal cord or meninges.
• Taking sedatives and hypnotics, phenytoin, carbamazepine, rifampin, and barbiturate.
• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, hepatic, renal, or metabolic disease).
• Subjects suffered from dementia, mental illness and other serious cognitive dysfunction.
• 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.
• Pregnant female. 10.Breast-feeding

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

Study Sites (1)

Guangdong General Hospital & Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yi Pan, Dr.

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Pan, Dr.

CONTACT

0086-13719188887; panyiff01@163.com

Study Design

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

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: August 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: June 1, 2021
• Last Updated: August 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)