Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects
- Conditions
- Cognitive Late EffectsCancer
- Registration Number
- NCT00255138
- Lead Sponsor
- Temple University
- Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- No ongoing pharmacological management of ADHD
- Not currently pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Conner's Parent Rating Scale (CPRS)
- Secondary Outcome Measures
Name Time Method Continuous Performance Test (CPT) Side Effects Rating Scale Conner's Teacher Rating Scale (CTRS)
Trial Locations
- Locations (1)
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Temple University🇺🇸Philadelphia, Pennsylvania, United States