The Impact of Chemotherapy on Memory Function and the Development of Traumatic Symptoms in Children With Cancer
|ClinicalTrials.gov Identifier: NCT01108952|
Recruitment Status : Unknown
Verified April 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 22, 2010
Last Update Posted : April 22, 2010
Background: While treatment for pediatric cancer has improved significantly over the past 40 years, the neurotoxic side-effects of the chemotherapy agents themselves are now being recognized. Two drugs suspected of having acute impact on memory performance in children are methotrexate (MTX) and steroids (GCs). In addition, new evidence suggests that this neurotoxicity might actually protect these children from traumatization.
Working hypothesis and aims: This project aims to examine the acute impact of MTX and GC chemotherapy on memory performance in children and young adults with cancer, and the subsequent impact on the development of traumatic symptoms. We hypothesize that MTX and GCs will each produce acute declines in memory performance and that children with greater reductions in memory performance will have fewer traumatic symptoms.
Methods: The investigators will recruit 45 children being treated with MTX or GCs at Dana Children's Hospital. To determine acute impact on memory, a battery of memory tests will be administered before and after a cycle of MTX and before and after a cycle of GCs. In addition, traumatic symptoms will be assessed at each post-chemotherapy evaluation point Expected results: The investigators expect poorer memory performance after MTX and after GCs and that these performance declines will correlate with lower rates of traumatic symptoms.
Importance: The immediate impact of MTX and GCs on memory is not well known, especially in children. In addition, recent findings have led us to hypothesize that chemotherapy-induced deficits in memory function would paradoxically protect these patients from the traumatization often associated with cancer and its treatment. The proposed study will test this novel hypothesis for the first time.
|Condition or disease|
|Oncology Trauma Pediatric|
|Study Type :||Observational|
|Estimated Enrollment :||45 participants|
|Official Title:||The Impact of Chemotherapy on Memory Function and the Development of Traumatic Symptoms in Children With Cancer|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108952
|Contact: Ronit Elhasid, MD||03 email@example.com|
|Tel Aviv Sourasky Medical Center||Recruiting|
|Tel Aviv, Israel|
|Principal Investigator:||Ronit Elhasid, MD||Tel-Aviv Sourasky Medical Center|