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 range18 Years
SexALL
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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
✕. 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.
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
✕. 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.