Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects

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

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

Study Overview

• Status: Withdrawn
• Conditions: Cancer; Cognitive Late Effects
• Intervention / Treatment: Drug: Atomoxetine

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Conner's Parent Rating Scale (CPRS)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Ronald T Brown, Ph.D., Temple University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2005

Study Registration Dates

• First Submitted: November 15, 2005
• First Submitted That Met QC Criteria: November 15, 2005
• First Posted (Estimate): November 17, 2005

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Children; Attention; Stimulants; Atomoxetine; Cognitive Late Effects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: 4463