Treatment-Related Cancer Clinical Trial
Official title:
Clonidine for the Treatment of Neurocognitive Sequelae Following Cancer Treatment in Children
The goals of the study are to determine the efficacy of clonidine in the treatment of children with neurocognitive sequelae following the therapy of long term malignancies. In addition, the study hopes to determine the long-term effect of clonidine on children's academic and psychosocial function.
The long term prognosis for many children diagnosed with brain tumors and other malignancies
has improved dramatically over the last decades and is expected to continue to rise as a
result of improved treatment. The increased survival in pediatric oncology, however, has
been associated with an increased recognition of neurobehavioral sequelae of cancer and its
treatment. Current understanding of the incidence, pathogenesis, and natural history of
these neurobehavioral abnormalities is limited and considerable individual variation in the
presence and severity of these complications has been noted. Central nervous system (CNS)
abnormalities associated with childhood cancer and its treatment have been demonstrated on
at least three levels which may be interrelated: neurobehavioral abnormalities, brain
imaging abnormalities, and neurotransmitter abnormalities.
Patients will be randomized to either clonidine or placebo. Study medication will be
administered in a double blind fashion beginning with a four-week dose titration period
followed by a four-week maintenance period. Total duration of dosing is 18 weeks. Patients
who derive a benefit from clonidine administration may continue for an additional 30 weeks
of therapy. PK samples will be collected at weeks 9 and 18.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03313193 -
Acupressure for Children in Treatment for a Childhood Cancer
|
N/A |