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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Herzog Hospital
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01108952
First received: April 21, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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
Oncology
Trauma
Pediatric

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Chemotherapy on Memory Function and the Development of Traumatic Symptoms in Children With Cancer

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 45
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

children with cancer

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108952

Contacts
Contact: Ronit Elhasid, MD 03 6974270 ronite@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Herzog Hospital
Investigators
Principal Investigator: Ronit Elhasid, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Ronit Elhasid, MD, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01108952     History of Changes
Other Study ID Numbers: TASMC-09-RE-687-CTIL
Study First Received: April 21, 2010
Last Updated: April 21, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Chemotherapy
Memory
Methotrexate
Glucocorticoids
Trauma
pediatric oncology
traumatization

ClinicalTrials.gov processed this record on September 30, 2014