Brain Integrity in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation

CompletedOBSERVATIONAL
Enrollment

416

Participants

Timeline

Start Date

April 26, 2013

Primary Completion Date

February 20, 2018

Study Completion Date

February 20, 2018

Conditions
Hodgkin Lymphoma
Interventions
OTHER

Neurocognitive Evaluation

The neurocognitive evaluation will include measures of academic achievement, intelligence, sustained attention, memory, processing speed, executive functions, functional behavior, and emotional functioning.

OTHER

Quantitative Brain Imaging

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.

OTHER

Neurologic Evaluation

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.

OTHER

Health Questionnaire

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.

OTHER

Vascular Testing

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.

OTHER

Cardiopulmonary Exercise Testing

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.

OTHER

Echocardiography

A complete 3D as well as 2D echocardiogram with Doppler and M-mode will be performed.

OTHER

Pulmonary Function Testing

Pulmonary function testing will include spirometry, lung volume measurements by body plethysmography, and single-breath carbon monoxide-diffusion capacity (DLCO).

PROCEDURE

Serum Biomarkers

Blood for serum biomarkers associated with cardiovascular morbidity will be drawn, including high-sensitivity C-reactive protein, serum homocysteine.

OTHER

Ophthalmology Examination

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.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

St. Jude Children's Research Hospital

OTHER

NCT01820117 - Brain Integrity in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation | Biotech Hunter | Biotech Hunter