OncologyNCT01108952
The Impact of Chemotherapy on Memory Function and the Development of Traumatic Symptoms in Children With Cancer
An observational study of Oncology and Trauma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 6 to 25 years
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Keywords
- Chemotherapy, Memory, Methotrexate, Glucocorticoids, Trauma, pediatric oncology, traumatization
- Medical subject headings
- Neoplasms, Wounds and Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Herzog Hospital
- Investigators
- Ronit Elhasid, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108952
- Sponsor's protocol ID
- TASMC-09-RE-687-CTIL
- Status last verified
- Apr 2010
- First submitted
- 21 Apr 2010
- Last updated
- 22 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chemotherapy on Memory Function and the Development of Traumatic Symptoms in Children With Cancer
- ClinicalTrials.gov ID
- NCT01108952
- Acronym / sponsor ID
- TASMC-09-RE-687-CTIL
- Keywords
- Chemotherapy, Memory, Methotrexate, Glucocorticoids, Trauma, pediatric oncology, traumatization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Herzog Hospital
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronit Elhasid, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Trauma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronit Elhasid, MD (03 6974270, ronite@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2010; AzTrials last refreshed its copy on 30 Oct 2026.