Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conner's Parent Rating Scale (CPRS)
Ronald T Brown, Ph.D.
United States: Food and Drug Administration
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