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Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors

6 Years
28 Years
Not Enrolling
Acute Lymphoblastic Leukemia

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Trial Information

Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors

Acute lymphoblastic leukemia (ALL) is the most prevalent childhood malignant disease.
Survival has improved from 5-10% in the early 1960s to over 80% at present. Historically,
the central nervous system (CNS) was the most common site of leukemia relapse. However,
major improvement in cure rates was achieved with the addition of CNS directed therapy using
initially craniospinal irradiation, and more recently, a combination of high-dose systemic
methotrexate and intrathecal chemotherapy.

ALL mostly afflicts children in the first 12-years of life, an age when progressive
myelination is taking place and the central nervous system is more vulnerable to chemical
and radiologic injury. Many ALL studies have reported neurologic adverse events related to
the treatment.

Little is known about the long-term outcome of neurologic toxicity developing during
treatment of leukemia, or development of new late onset neurologic complications. No data
is available about outcomes of non-behavioral/cognitive neurologic complications, such as
seizures, incoordination, headache, loss of motor or sensory function, impaired energy and
muscle weakness. In addition, there is no data available on impact of neurologic disability
on quality of life of ALL survivors.

It is important to understand and recognize neurologic disability, its causes and impact on
function and quality of life so that adequate and timely remedies can be offered through
education and appropriate interventions can be undertaken to help prevent long-term

This is a prospective observational study of ALL St. Jude Children's Research Hospital
survivors to determine the prevalence of different headache syndromes, as defined by
International Society of Headache criteria (IHS) and the prevalence and severity of seizures
and their relationship to leukemia treatment. We will establish incidence, type, severity,
and disability of sensory-motor neuropathy when present or any long term progression of
initial peripheral nerve injury in ALL survivors. This study will also help define whether
there is a higher incidence of low back pain and if there is any relation to a specific

Subjects will have a one-time evaluation with an investigator administered questionnaire and
a neurologic examination.

Inclusion Criteria:

- Childhood ALL survivors treated on institutional protocols at

- Patient will be at least 5-years from ALL diagnosis.

- Patient will be at least one year from completion of cancer therapy.

- Absence of recurrent or secondary cancer for at least one year day of enrollment.

- Between 6-28 years of age at the time of evaluation.

- Patient's or at least one parent's English is proficient enough Questionnaire.

- Parent and the child agree to participate. Consent only from will suffice if > 18
years of age at the time of assessment.

Exclusion Criteria:

- Recurrent tumor or development of secondary cancer

- Child or parent refuses to participate

- Co-morbid pre-existing disabling neurologic disease, which in the judgment of the
principal investigator may compromise clinical observations.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

To estimate prevalence of neurologic symptoms as reported by the patient or parent in childhood acute lymphoblastic leukemia survivors.

Outcome Time Frame:

At lease 5 years from diagnosis and at least one year after completion of therapy.

Safety Issue:


Principal Investigator

Kirsten Ness, PT, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Institutional Review Board

Study ID:




Start Date:

August 2005

Completion Date:

October 2008

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia
  • ALL survivors
  • ALL neurologic symptoms
  • ALL neurologic disability
  • ALL late effects
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794