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The purpose of the study is to evaluate the effect of simvastatin in combination with radiotherapy on the clinical outcomes of patients with brain metastases.
Despite current advances in therapies, the outcome for patients with brain metastases is fatal. New therapeutic approaches, such as radiosensitizing agents, are needed to provide a significant survival advantage for those patients. Statins have been reported to enhance the efficacy of radiotherapy in addition to a neuroprotective effect. The aim of the study is to evaluate the effect of simvastatin on the efficacy and safety of radiation therapy in patients with brain metastases and on improving patients' quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simvastatin | Experimental | they will receive simvastatin in addition to radiation therapy |
|
| control | Active Comparator | they will receive radiation therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simvastatin in addition to radiation therapy | Drug | simvastatin 80 mg tablet once daily during the radiation therapy period in addition to radiation therapy 30 Gy delivered in 10 fractions over 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| a- Response rate | brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size | 4 weeks after radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| progression free and overall survival | it measures time from treatment initiation to either progression or death from any cause | up to 6 months |
| adverse effects | any adverse/side effect will be evaluated |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | measures the patient quality of life | baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks |
| cognitive function assessment using Montreal cognitive assessment test | assess the patient cognitive function by the evaluation of Montreal cognitive assessment test score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| May A Shawki, master | Faculty of Pharmacy- Ain Shams university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams university Hospitals | Cairo | 11566 | Egypt |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| radiation therapy | Radiation | radiation therapy 30 Gy delivered in 10 fractions over 2 weeks |
|
| during the treatment period |
| baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks |
| serum s100 B protein | evaluate serum s100 B protein at baseline and after 2 weeks | baseline, after radiation therapy |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013812 | Therapeutics |