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NCT00457210 Clinical Trial

The Influence of Radiotherapy on Cognitive Function

Quality of Life Clinical Trial

Official title:
The Influence of the Radiotherapy or Stereotactic Radiosurgery on the Cognitive Function of the Patients With the Neurotrax Assessment System and a Cognitive Questionnaire.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00457210
Other study ID # TASMC-07-BC-040-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 5, 2007
Last updated April 5, 2007
Start date April 2007

Study information
Verified date April 2007
Source Tel-Aviv Sourasky Medical Center
Contact Ben Corn, MD
Phone 972-52-426-6533
Email bencorn@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel:The Ministry of Health
Study type Observational

Clinical Trial Summary

The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain will be assessed at 3 time points before and after the treatment.

Description:

The basic cognitive function and QOL of 150 oncologic patients that undergone Radiotherapy or Radiosurgery treatment to the brain due to primary tumor, metastases or increased risk of brain metastases, will be assessed at 3 time points: before the treatment, immediately after the treatment, and on the next follow up visit. The assessment tools that will be used are Neurotrax standard cognitive computerized tests and 2 short questionnaires.Patients that will receive a one-day treatment will be tested on 2 time points only- before the treatment and on FU.The research will reveal the positive and the negative influences of the Radiotherapy, along with the assessment of norms for the cognitive function and quality of life of oncologic patients being treated by RT.Eligibility criteria:oncologic patients of both genders, with primary brain tumors, metastases or with increased risk of brain metastases, that are referred to conformal/palliative or preventive Radiotherapy treatment or to Stereotactic Radiosurgery, who are able to follow instructions in Hebrew.The participants will be 20-80 years old.Main comparisons will be performed between the cognitive tests results on 3 time points mentioned. The study will continue until the needed number of participants will be achieved.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- 20-80 years old oncologic patients, of both genders, that are referred to Brain Radiotherapy or Stereotactic Radiosurgery due to primary brain tumor/ brain metastases or increased risk for brain metastases.

- Are able to follow instructions in Hebrew.

Exclusion Criteria:

- Non-Hebrew speakers can not participate.

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Procedure:
• Brain Radiotherapy/Stereotactic Radiosurgery

Locations
Country Name City State
Israel Tel Aviv sourasky Medical Center Tel Aviv

Sponsors (2)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center Mindstreams

Country where clinical trial is conducted

Israel, 

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