Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases (NCT01445483) | Clinical Trial Compass
CompletedNot Applicable
Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases
United States35 participantsStarted 2009-04-17
Plain-language summary
Background:
* There are no standardized sets of tests to measure changes in neuropsychological functioning in patients treated for brain metastasis (cancer that has spread beyond the original site to the brain).
* Neuropsychological function has an important effect on quality of life and should be included when determining treatment options.
Objectives:
* To find out if there is a change in patients cognitive (thinking) and daily functioning after standard radiation treatment for brain metastasis that can be measured with tests.
* To see if any changes on these tests are related to patients response to radiation therapy.
Eligibility:
\- Patients 18 years of age or older who have cancer that has spread to the brain.
Design:
* Patients receive a 2-week course of radiation therapy to the brain, given daily 5 days a week. Some patients may require stereotactic radiosurgery (an additional boost of radiation therapy to specific sites of brain metastasis).
* Patients have the following evaluations before and after treatment to determine changes in cognition and functioning:
* Neuropsychological testing to measure cognitive (thinking) abilities like memory, attention, processing speed, and reading, and fine motor skills.
* Questionnaires to assess quality of life and daily living skills.
* Patients have MRI scans and blood and urine tests.
* At the completion of radiation treatment, patients return to the clinic for follow-up visits at 1, 2, 4, 6, 9 and 12 months for blood and urine tests, physical examination, MRI of the brain, neuropsychological testing and assessments of quality of life and daily living skills.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must be 18 years of age or older.
. Pathologically confirmed primary malignancy with at least one intraparenchymal brain metastasis as identified on brain MRI scan with intravenous contrast.
. Patient must have a primary medical or surgical oncologist in the community or at NCI who is willing to collaborate with the ROB staff in the clinical management of the patient.
. All patients must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study BEFORE any of the protocol related studies are preformed (this does not include routine laboratory tests or imaging studies required to establish eligibility).
. Subjects of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study tracked specific thinking and memory skills — like word recall, attention, and hand coordination — in people getting radiation for brain metastases. Can you help me understand which of these functions might be affected by the type of radiation treatment you're recommending for me, and how closely you'd monitor those changes?
2Since this trial has already been completed, have its findings changed how you approach monitoring neuropsychological side effects in patients like me who are being treated for brain metastases?
3The study measured things like the Hopkins Verbal Learning Test and Trailmaking Test — are these kinds of cognitive assessments something you would use to track my brain function before and after radiation, and if not, how would we know if my thinking or memory was being affected?
4Brain metastases can be treated in different ways, including whole-brain radiation or more targeted approaches like stereotactic radiosurgery — does the evidence from studies like this one influence which option you think is safer for preserving cognitive function in my situation?
5If I do experience declines in memory, attention, or coordination during or after radiation treatment, what support or interventions would be available to help me manage those changes?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neuropsychological function
Timeframe: Completion of study
2
Test scores for: Hopkins Vrbl Learning Test recall; WAIS-III Digit Span; the WAIS-III Symbol Search; the Ruff 2 & 7 Selective Attn. The Trailmaking Tst Part B speed z-score; and the Grooved Pegboard Test dominant hand z-score
. Cognitively impaired patients who cannot give informed consent, including patients assigned a power of attorney for medical decisions.
. Inability to communicate in the English language.
. Pre- existing or active psychiatric or neurologic impairments, not caused by the brain metastasis, which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol.
. Prior Therapy
. Concurrent Therapy
. Patients needing emergent radiation therapy for their brain metastases will be excluded.
. Patients must not have evidence of leptomeningeal metastases.