Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Simvastatin Effect on Radiation Therapy of Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104193
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
MAy Ahmed Shawki, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Brain Metastases Drug: simvastatin in addition to radiation therapy Radiation: radiation therapy Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Simvastatin on the Clinical Outcome of Patients With Brain Metastases Treated With Radiation Therapy: a Pilot Study
Study Start Date : April 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Experimental: simvastatin
they will receive simvastatin in addition to radiation therapy
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

Active Comparator: control
they will receive radiation therapy only
Radiation: radiation therapy
radiation therapy 30 Gy delivered in 10 fractions over 2 weeks




Primary Outcome Measures :
  1. a- Response rate [ Time Frame: 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 Outcome Measures :
  1. progression free and overall survival [ Time Frame: up to 6 months ]
    it measures time from treatment initiation to either progression or death from any cause

  2. adverse effects [ Time Frame: during the treatment period ]
    any adverse/side effect will be evaluated


Other Outcome Measures:
  1. quality of life [ Time Frame: baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks ]
    measures the patient quality of life

  2. cognitive function assessment using Montreal cognitive assessment test [ Time Frame: baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks ]
    assess the patient cognitive function by the evaluation of Montreal cognitive assessment test score

  3. serum s100 B protein [ Time Frame: baseline, after radiation therapy ]
    evaluate serum s100 B protein at baseline and after 2 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104193


Locations
Layout table for location information
Egypt
Ain Shams university Hospitals
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Principal Investigator: May A Shawki, master Faculty of Pharmacy- Ain Shams university

Layout table for additonal information
Responsible Party: MAy Ahmed Shawki, teaching assisstant, Ain Shams University
ClinicalTrials.gov Identifier: NCT02104193     History of Changes
Other Study ID Numbers: PH CL 25
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Keywords provided by MAy Ahmed Shawki, Ain Shams University:
brain metastases
simvastatin
radiation therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors