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Clinical Trials/NCT00255138
NCT00255138
Withdrawn
Phase 3

Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers

Temple University1 site in 1 countryNovember 2005

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Cancer
Sponsor
Temple University
Locations
1
Primary Endpoint
Conner's Parent Rating Scale (CPRS)
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Conner's Parent Rating Scale (CPRS)

Secondary Outcomes

  • Conner's Teacher Rating Scale (CTRS)
  • Continuous Performance Test (CPT)
  • Side Effects Rating Scale

Study Sites (1)

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