Brain Integrity in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation
2 other identifiers
observational
416
1 country
1
Brief Summary
While thoracic radiation therapy (TRT) has been a primary component in successful treatment of a variety of childhood and adult cancers, the exposure to this treatment has been associated with significant cardiovascular and pulmonary morbidity in long-term survivors. Within non-cancer populations, cardiovascular and pulmonary morbidity is associated with increased risk for cerebral vascular accidents (CVAs), accelerated brain atrophy and neurocognitive impairment. Patients with chronic heart disease demonstrate problems with attention, processing speed, memory, and executive functions. Chronic pulmonary disease also increases the risk of stroke, leukoencephalopathy, and neurocognitive impairment in non-cancer populations. The investigators propose to examine indices of brain integrity, including neurocognitive performance and brain MRI/MRA, in long-term adult survivors of Hodgkin lymphoma (HL) treated with thoracic radiation and no direct central nervous system therapy. OBJECTIVES:
- 1.To evaluate brain integrity in adult survivors of childhood HL treated with thoracic radiation therapy.
- 2.To identify therapeutic factors associated with brain integrity in adult survivors of childhood HL who are at risk for cardiac and pulmonary morbidity.
- 3.To examine associations between cardiac, vascular and pulmonary health and brain integrity in adult survivors of childhood HL treated with thoracic radiation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2013
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedStudy Start
First participant enrolled
April 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2018
CompletedMarch 1, 2018
February 1, 2018
4.8 years
March 21, 2013
February 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Neurocognitive measures of sustained attention and memory between HL survivor group and control group.
To evaluate brain integrity in adult survivors of childhood cancer treated with thoracic radiation therapy. Two-sided two-sample t test will be conducted to compare the difference of neurocognitive impairment in area of sustained attention and memory in the HL survivors and matched controls.
Once, at or near enrollment
Rate of leukoencephalopathy and hemosiderin deposits on quantitative MRI between HL survivor group and control group.
To evaluate brain integrity in adult survivors of childhood cancer treated with thoracic radiation therapy. Two-sided two-sample proportional test will be used to compare the rates of leukoencephalopathy and hemosiderin deposits between in the HL survivors and matched controls.
Once, at or near enrollment
Rate of neurologic symptoms between HL survivor group and control group.
To evaluate brain integrity in adult survivors of childhood cancer treated with thoracic radiation therapy. Two-sided two-sample proportional test will be used to compare the rates of neurologic symptoms between the HL survivors and matched controls.
Once, at or near enrollment
Secondary Outcomes (2)
Association between thoracic radiation dose and sustained attention and memory scores and rate of leukoencephalopathy and hemosiderin deposits in HL survivors.
Once, at or near enrollment
Association between cardiac, vascular and pulmonary health and sustained attention and memory scores and rate of leukoencephalopathy and hemosiderin deposits.
Once, at or near enrollment
Study Arms (2)
Hodgkin lymphoma
Participants previously treated at St. Jude Children's Research Hospital with thoracic radiation therapy for Hodgkin lymphoma. Interventions: Neurocognitive Evaluation, Quantitative Brain Imaging, Neurologic Evaluation, Comprehensive Health Questionnaire, Vascular Testing, Cardiopulmonary Exercise Testing, Echocardiography, Pulmonary Function Testing, Serum Biomarkers, and Ophthalmology Examination.
Normal control
A group of healthy individuals matched for age, sex and race. Interventions: Neurocognitive Evaluation, Quantitative Brain Imaging, Neurologic Evaluation, Comprehensive Health Questionnaire, Vascular Testing, Cardiopulmonary Exercise Testing, Echocardiography, Pulmonary Function Testing, Serum Biomarkers, and Ophthalmology Examination.
Interventions
The neurocognitive evaluation will include measures of academic achievement, intelligence, sustained attention, memory, processing speed, executive functions, functional behavior, and emotional functioning.
Imaging will include raw images to both quantify white matter hyperintensities and hemosiderin deposits, as well as cortical thickness and tissue segmentation. Brain imaging will be repeated on participants who are concurrently enrolled on BRIGHT and MIND protocols at St. Jude and who completed prior brain imaging during the BRIGHT clinic visit. The repeat MRI will be done at their 6 month MIND clinic visit.
Evaluation includes a complete review of neurologic symptoms, and interview and examination by the neurologist, assessment of neurologic symptoms and determination of their impact on day-to-day living, and quantified neurologic examination by the neurologist.
Participants will be asked to complete an approximately 450-item survey to assess health history and status, social and demographic factors, health behaviors, and psychosocial constructs.
Digital assessment of endothelial function will be studied, and central blood and pulse pressure and carotid-femoral pulse wave velocity will be non-invasively measured.
Study participants will undergo cardiopulmonary exercise testing by treadmill. Those participants whose physical performance does not permit walking safely on the treadmill (extreme deconditioning, lower extremity paralysis, balance disorder, acute lower extremity injury) will perform cardiopulmonary exercise testing on a bicycle or upper extremity ergometer using a comparable testing protocol.
A complete 3D as well as 2D echocardiogram with Doppler and M-mode will be performed.
Pulmonary function testing will include spirometry, lung volume measurements by body plethysmography, and single-breath carbon monoxide-diffusion capacity (DLCO).
Blood for serum biomarkers associated with cardiovascular morbidity will be drawn, including high-sensitivity C-reactive protein, serum homocysteine.
Ophthalmology examination will include a review of symptoms, examination, and fundus imaging. The examination will consist of visual acuity testing, refraction testing, retinoscopy, ocular pressure, and examination under mydriasis. Fundus photography will be used to capture an image of the retina for examination of potential hypertensive retinopathy.
Eligibility Criteria
SJLIFE is an institutional initiative to establish a lifetime survivor cohort to study physical and behavioral health outcomes in adult survivors of childhood cancer. This protocol includes individuals diagnosed and treated with a malignancy during childhood at SJCRH since 1962, who are now 10 or more years from diagnosis and over 18 years of age. The current study will recruit participants from the SJLIFE cohort who received thoracic radiation as part of their treatment for Hodgkin lymphoma. Potentially eligible comparison group participants will be recruited from the relative or friend population who accompany any After Completion of Therapy (ACT) or SJLIFE patient for follow-up at SJCRH.
You may qualify if:
- Current St. Jude LIFE protocol Participant, treated with thoracic radiation
- Currently ≥ 18 years of age
- ≥ 10 years from original diagnosis
You may not qualify if:
- Has participated in the previous pilot study at St. Jude (HPP16)
- History of cranial or total-body radiation therapy
- History of intrathecal Methotrexate, high-dose Methotrexate or high-dose Cytarabine.
- History of head injury or diagnosis of a genetic disorder associated with neurocognitive impairment
- Pre-existing known neurocognitive impairment prior to diagnosis of Hodgkin lymphoma
- History of congenital heart disease reported in the literature to be associated with neurocognitive status as determined by the principal investigators
- Currently pregnant
- Secondary central nervous system neoplasm
- Research participant is a sibling, parent, relative or friend of a current or former St. Jude patient
- Research participant must be at least 18 years of age at the time of the scheduled evaluation
- History of cranial, total-body or thoracic radiation therapy
- History of intrathecal Methotrexate, high-dose Methotrexate, or high-dose Cytarabine.
- History of head injury or diagnosis of a genetic disorder associated with neurocognitive impairment
- Known neurocognitive impairment
- History of congenital heart disease reported in the literature to be associated with neurocognitive status as determined by the principal investigators
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
Biospecimen
Blood (5 ml) will be collected, frozen and stored for future serum biomarker assays.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Krull, PhD
St. Jude Children's Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2013
First Posted
March 28, 2013
Study Start
April 26, 2013
Primary Completion
February 20, 2018
Study Completion
February 20, 2018
Last Updated
March 1, 2018
Record last verified: 2018-02