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


Phase 3
6 Years
18 Years
Not Enrolling
Both
Cancer, Cognitive Late Effects

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Conner's Parent Rating Scale (CPRS)

Principal Investigator

Ronald T Brown, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Temple University

Authority:

United States: Food and Drug Administration

Study ID:

4463

NCT ID:

NCT00255138

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Cancer
  • Cognitive Late Effects
  • Cancer
  • Cognitive Late Effects
  • Stimulants
  • Atomoxetine
  • Attention
  • Children

Name

Location

Temple University Philadelphia, Pennsylvania  19140