Randomized study on memantine for Prevention of Cognitive impairment in brain metastasis patients
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2022/01/039599
- Lead Sponsor
- Amrita Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients of either gender aged 18 years and older.
Patients must have a pathologically proven diagnosis of solid malignancy with brain metastases visible on contrast-enhanced- MRI (or CT for patients unable to have an MRI).
Patient is able (i.e., sufficiently fluent) and willing to complete the cognitive function test and the quality-of-life questionnaires either in English or Malayalam
ECOG performance status 0, 1, or 2.
Serum creatinine must be <3g/dl within 28 days prior to registration.
No memantine allergy
No current alcohol or drug abuse
No chronic use of benzodiazepines
No severe active comorbidity
Patients who are not willing to participate in the study
Patients who have psychiatric illness, drug abuse, mental retardation (premorbid intelligence quotient <70)
Prior cranial external beam radiotherapy
Current use of NMDA antagonists, such as amantadine, ketamine, or dextromethorphan.
Diagnosis of chronic liver disease/cirrhosis of the liver (e.g., Child-Pugh class B or C).
Positive serum pregnancy test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine whether the addition of memantine in radiotherapy for brain metastasis preserve the cognitive function at 6 months compared to a placeboTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Impact of memantine in preserving cognitive functions in brain metastatic patients treated with Stereotactic Radiosurgery (SRS).Timepoint: 6 months;Impact of memantine in preserving cognitive functions in brain metastatic patients treated with Whole Brain Radiotherapy (WBRT).Timepoint: 6 months;Impact of memantine inpreserving cognitive functions in brain metastatic patients treated with Hippocampal Avoidance Whole Brain Radiotherapy (HA-WBRT).Timepoint: 6 months;To assess the quality of life of patients receiving brain irradiation with or without memantine.Timepoint: 6 months;To assess the safety and tolerability of MemantineTimepoint: 6 months