Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.
Full 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.
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
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Trial contacts and locations
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Data sourced from clinicaltrials.gov
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