Non Hodgkin Lymphoma Clinical Trial

Brain Integrity in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation

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:

To evaluate brain integrity in adult survivors of childhood HL treated with thoracic radiation therapy.
To identify therapeutic factors associated with brain integrity in adult survivors of childhood HL who are at risk for cardiac and pulmonary morbidity.
To examine associations between cardiac, vascular and pulmonary health and brain integrity in adult survivors of childhood HL treated with thoracic radiation.

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Full Description

This is an observational study to collect health data from long-term survivors of Hodgkin lymphoma (HL). Data will be collected once at participant enrollment. The long-term effects of thoracic radiation therapy (TRT) given earlier as part of the treatment for HL will be examined in long-term survivors and compared to health data collected from normal volunteers.

HL survivors who were treated at St. Jude Children's Research Hospital (SJCRH) with TRT will be recruited to complete a comprehensive neurocognitive evaluation, brain MRI/MRA, a clinical neurological exam, peripheral pulse contour analysis, non-invasive central blood pressure monitoring, cardiopulmonary exercise testing, and serum biomarkers related to cardiac disease. As part of their standard St. Jude LIFE protocol evaluation, they also complete an echocardiogram, pulmonary function tests and questionnaires designed to evaluate broad health, psychological, socioeconomic and environmental factors that impact everyday life.

A comparison sample of healthy individuals, frequency-matched on age, sex and race will also be recruited. The comparison group will complete the comprehensive neurocognitive evaluation, brain MRI/MRA, clinical neurological exam, pulse contour analysis, non-invasive central blood pressure monitoring, and cardiopulmonary exercise testing. Through the St. Jude LIFE protocol, the comparison sample will also complete an echocardiogram, pulmonary function tests and questionnaires designed to evaluate broad health, psychological, socioeconomic and environmental factors that impact everyday life.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria - HL participant:

Current St. Jude LIFE protocol Participant, treated with thoracic radiation
Currently ≥ 18 years of age
≥ 10 years from original diagnosis

Exclusion Criteria - HL participant:

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

Inclusion Criteria - Normal Control:

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

Exclusion Criteria - Normal Control:

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
Currently pregnant
Central nervous system neoplasm

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

416

Study ID:

NCT01820117

Recruitment Status:

Completed

Sponsor:

St. Jude Children's Research Hospital

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There is 1 Location for this study

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St. Jude Children's Research Hospital
Memphis Tennessee, 38105, United States

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Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

416

Study ID:

NCT01820117

Recruitment Status:

Completed

Sponsor:


St. Jude Children's Research Hospital

How clear is this clinincal trial information?

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