Simvastatin Effect on Radiation Therapy of Brain Metastases

Brain Metastases Clinical Trial

Official title:

The Effect of Simvastatin on the Clinical Outcome of Patients With Brain Metastases Treated With Radiation Therapy: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104193
• Other study ID #: PH CL 25
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2014
• Last updated: February 16, 2016
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• 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

Radiation:
• radiation therapy
radiation therapy 30 Gy delivered in 10 fractions over 2 weeks

Locations

Country	Name	City	State
Egypt	Ain Shams university Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life	measures the patient quality of life	baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks	No
Other	cognitive function assessment using Montreal cognitive assessment test	assess the patient cognitive function by the evaluation of Montreal cognitive assessment test score	baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks	Yes
Other	serum s100 B protein	evaluate serum s100 B protein at baseline and after 2 weeks	baseline, after radiation therapy	No
Primary	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	No
Secondary	progression free and overall survival	it measures time from treatment initiation to either progression or death from any cause	up to 6 months	No
Secondary	adverse effects	any adverse/side effect will be evaluated	during the treatment period	Yes