- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00255138
Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects
Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In previous years, it had often been assumed that cognitive and behavioral declines in children who survived cancer therapy were largely a function of the prophylactic therapies (e.g., radiation, chemotherapy) that these children had received. Regardless of the etiologies of these specific late effects, the data regarding the long-term outcome of these children are strikingly consistent. Generally, the studies to date suggest significant impairments in attention and concentration that result in marked declines in academic performance and social and behavior difficulties.
Despite the clear evidence of problems with attention and concentration, as well as associated fucntional impairments (e.g., poor academic achievement and poor peer relationships), there have been few clinical trials designed to manage the cogntive late effects and neurological toxicities associated with radiation therapy and chemotherapy for children and adolescents who have survived cancer.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Temple University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 6-18
- Patient has received chemotherapy, radiation, or a combination of both.
- Patient is at least 12 months post-competion of therapy but no more than five years post-completion of therapy.
Exclusion Criteria:
- No ongoing pharmacological management of ADHD
- Not currently pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Conner's Parent Rating Scale (CPRS)
|
Secondary Outcome Measures
Outcome Measure |
---|
Continuous Performance Test (CPT)
|
Conner's Teacher Rating Scale (CTRS)
|
Side Effects Rating Scale
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ronald T Brown, Ph.D., Temple University
Study record dates
Study Major Dates
Study Start (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4463
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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