Brain Metastases
Conditions
Keywords
brain metastases, simvastatin, radiation therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGsimvastatin in addition to radiation therapy
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
RADIATIONradiation therapy
radiation therapy 30 Gy delivered in 10 fractions over 2 weeks
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with measurable brain metastases * Age more than 18 years old * Patients should be planned for radiation therapy
Exclusion criteria
* Renal dysfunction (more than 1 upper normal level) * Hepatic dysfunction (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>3 times the upper normal level ) * Pregnancy or lactation. * Known hypersensitivity to simvastatin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| a- Response rate | 4 weeks after radiation therapy | brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free and overall survival | up to 6 months | it measures time from treatment initiation to either progression or death from any cause |
| adverse effects | during the treatment period | any adverse/side effect will be evaluated |
Other
| Measure | Time frame | Description |
|---|---|---|
| quality of life | baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks | measures the patient quality of life |
| cognitive function assessment using Montreal cognitive assessment test | baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks | assess the patient cognitive function by the evaluation of Montreal cognitive assessment test score |
| serum s100 B protein | baseline, after radiation therapy | evaluate serum s100 B protein at baseline and after 2 weeks |
Countries
Egypt
Outcome results
None listed