Ignite Creation Date:
2024-05-05 @ 10:26 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01108952
Status:
UNKNOWN
Last Update Posted:
2010-04-22
First Post:
2010-04-21
Brief Title:
The Impact of Chemotherapy on Memory Function and the Development of Traumatic Symptoms in Children With Cancer
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
The Impact of Chemotherapy on Memory Function and the Development of Traumatic Symptoms in Children With Cancer
Status:
UNKNOWN
Status Verified Date:
2010-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Childrens 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
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 Childrens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None