Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00664131
First received: April 21, 2008
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

Treatment of acute lymphoblastic leukemia achieves high cure rate, but is potentially neurotoxic.

Long-term neurologic morbidity in survivors and its effect on function are inadequately studied.

Neurologic outcomes will be assessed through an investigator administered questionnaire followed by comprehensive neurologic examination by the study neurologist.


Condition Intervention
Acute Lymphoblastic Leukemia
Other: Neurological Examination/Questionnaires

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • To estimate prevalence of neurologic symptoms as reported by the patient or parent in childhood acute lymphoblastic leukemia survivors. [ Time Frame: At lease 5 years from diagnosis and at least one year after completion of therapy. ] [ Designated as safety issue: Yes ]
  • To estimate prevalence of neurologic signs as determined by detailed neurologic examination of childhood acute lymphoblastic leukemia survivors. [ Time Frame: At lease 5 years from diagnosis and at least one year after completion of therapy. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate prevalence of neurologic disability as determined by neurologic symptoms, signs and administered questionnaire instruments. [ Time Frame: At lease 5 years from diagnosis and at least one year after completion of therapy. ] [ Designated as safety issue: Yes ]
  • To explore risk factors for development of neurologic disability. [ Time Frame: At lease 5 years from diagnosis and at least one year after completion of therapy. ] [ Designated as safety issue: No ]
  • To assess effect of neurologic disability on quality of life. [ Time Frame: At lease 5 years from diagnosis and at least one year after completion of therapy. ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: August 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: Neurological Examination/Questionnaires
See Detailed Description section for description of treatment plan.

Detailed Description:

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 morbidity.

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 treatment.

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

  Eligibility

Ages Eligible for Study:   6 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Survivors of ALL who are currently 6-28 years of age, 5 years from ALL diagnosis, and 1 year off therapy who were treated on institutional protocols at St. Jude Children's Research Hospital. Survivors will be recruited in the Leukemia and ACT clinics at St. Jude Children's Research Hospital. We anticipate that 494 survivors are available. We plan to enroll every survivor who is eligible and visits Leukemia or/ and ACT clinic at St. Jude Children's Research Hospital

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664131

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Kirsten Ness, PT, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00664131     History of Changes
Other Study ID Numbers: ALLNOQ
Study First Received: April 21, 2008
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Acute Lymphoblastic Leukemia
ALL survivors
ALL neurologic symptoms
ALL neurologic disability
ALL late effects

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014