Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.

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Detailed Description

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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.

Conditions

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Cancer Cognitive Late Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atomoxetine

Intervention Type DRUG

Eligibility Criteria

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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.