ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
Herzog Hospital
Information provided by:
Tel-Aviv Sourasky Medical Center

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 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
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
Study Start Date : January 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory





Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: April 22, 2010
Last Verified: April 2010

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

Additional relevant MeSH terms:
Neoplasms