Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00255138
• Other study ID #: 4463
• Status: Withdrawn
• Phase: Phase 3
• Start date: November 2005

Study information

• Verified date: March 2022
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cognitive Late Effects

Intervention

Drug:
• Atomoxetine

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conner's Parent Rating Scale (CPRS)
Secondary	Conner's Teacher Rating Scale (CTRS)
Secondary	Continuous Performance Test (CPT)
Secondary	Side Effects Rating Scale