The Impact of Chemotherapy on Memory Function and the Development of Traumatic Symptoms in Children With Cancer

Trauma Clinical Trial

Official title:

The Impact of Chemotherapy on Memory Function and the Development of Traumatic Symptoms in Children With Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01108952
• Other study ID #: TASMC-09-RE-687-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: April 21, 2010
• Last updated: April 21, 2010
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ronit Elhasid, MD
• Phone: 03 6974270
• Email: ronite[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 25 Years

Eligibility

Inclusion Criteria:

• Histologically proven diagnosis of acute lymphoblastic leukemia, non-Hodgkin's lymphoma, or osteosarcoma

• treatment protocol that includes at least one cycle of methotrexate or exogenous glucocorticoid

• informed consent to participate in the study, according to institutional guidelines

• fluency in Hebrew, English, or Arabic

• age 6 to 25

Exclusion Criteria:

• Cranial irradiation within the past year

• serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study

• active meningitis or seizures occurring less than a month before study enrollment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Oncology
• Pediatric
• Trauma

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Herzog Hospital

Country where clinical trial is conducted

Israel,