Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Memantine: Dosing criteria for memantine/placebo: Week 1 will receive a single 5 mg morning dose followed by the addition of a 5 mg dose in the evening during week 2. In week 3, the mor
Sponsors
Amrita Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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 No memantine allergy No current alcohol or drug abuse No chronic use of benzodiazepines No severe active comorbidity
Exclusion criteria
Exclusion criteria: Patients who are not willing to participate in the study Patients who have psychiatric illness, drug abuse, mental retardation (premorbid intelligence quotient 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Impact of memantine in preserving cognitive functions in brain metastatic patients treated with Whole Brain Radiotherapy (WBRT).Timepoint: 6 months;Impact of memantine in preserving cognitive functions in brain metastatic patients treated with Stereotactic Radiosurgery (SRS).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 | — |
Countries
India
Contacts
Public ContactHaripriya P S
Amrita Institute of Medical Sciences
Outcome results
None listed