Simvastatin Effect on Radiation Therapy of Brain Metastases

NCT ID: NCT02104193

Last Updated: 2016-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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simvastatin

they will receive simvastatin in addition to radiation therapy

Group Type EXPERIMENTAL

simvastatin in addition to radiation therapy

Intervention Type 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

control

they will receive radiation therapy only

Group Type ACTIVE_COMPARATOR

radiation therapy

Intervention Type RADIATION

radiation therapy 30 Gy delivered in 10 fractions over 2 weeks

Interventions

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simvastatin 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

Intervention Type DRUG

radiation therapy

radiation therapy 30 Gy delivered in 10 fractions over 2 weeks

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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MAy Ahmed Shawki

teaching assisstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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May A Shawki, master

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmacy- Ain Shams university

Locations

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Ain Shams university Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PH CL 25

Identifier Type: -

Identifier Source: org_study_id

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