Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation

Sponsor

St. Jude Children's Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03361020

Collaborator

National Cancer Institute (NCI) (NIH), University of California, San Diego (Other)

440

Enrollment

Location

60.3

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

While thoracic radiation therapy (TRT) has been a primary component in successful treatment of Hodgkin lymphoma, exposure to this treatment has been associated with significant cardiovascular, cerebrovascular, and pulmonary morbidity in long-term survivors. Survivors of Hodgkin lymphoma (HL) are also at risk for fatigue and excessive daytime sleepiness. Insufficient sleep is recognized as an important public health concern, and is associated with cardiovascular disease, diabetes, obesity, neurocognitive problems, and reduced quality of life and productivity.

Survivors of HL, who are already at risk for cardiac and neurologic morbidity due to their treatment exposures, could face catastrophic cardiovascular and cerebrovascular events with the added risk associated with obstructive sleep apnea (OSA). The investigators propose to examine indices of sleep quality using polysomnography, and associated neurocognitive performance, brain MRI, and structure and strength of neck muscles in 220 long-term adult survivors of Hodgkin lymphoma treated with thoracic radiation.

OBJECTIVES:

To estimate the prevalence of OSA in adult survivors of HL treated with thoracic radiation, and compare the frequency to community controls matched on age, gender, race and body mass index.
To identify specific therapeutic factors associated with OSA in adult survivors of HL treated with thoracic radiation.
To identify biomarkers of OSA in adult survivors of HL treated with thoracic radiation.
To examine associations between OSA and cardiac morbidity and brain integrity in the adult survivors of HL treated with thoracic radiation.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Hodgkin Lymphoma

Detailed Description

Hodgkin lymphoma (HL) survivors being following at St. Jude within the SJLIFE protocol cohort who were treated with TRT will be recruited to complete a comprehensive neurocognitive evaluation, overnight polysomnography evaluation, brain and neck MRI, cervical strength testing, and serum biomarkers related to cardiac disease. As part of their standard SJLIFE evaluation, they will also complete an echocardiogram, pulmonary function tests and questionnaires designed to evaluate broad health, emotional, socioeconomic and environmental factors that impact everyday life.

The investigators will also recruit a comparison sample of healthy individuals matching on age, sex, race and body mass index. The comparison group will complete the comprehensive neurocognitive evaluation, overnight polysomnography, neck MRI, and cervical strength testing.

Study Design

Study Type:

Observational

Anticipated Enrollment :

440 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation

Actual Study Start Date :

Jan 23, 2018

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Hodgkin Lymphoma Participants will be survivors of Hodgkin Lymphoma (HL) who were treated with thoracic radiation during the course of their HL, who meet eligibility criteria, and who consent to this study.
Control Group The Comparison or control group members will be recruited from healthy parents, sibling, relative or friends who accompany the participant for follow-up at SJCRH and who meet eligibility criteria.

Outcome Measures

Primary Outcome Measures

Number of participants with obstructive sleep apnea (OSA) compared between groups [Once, at enrollment]
The comparison will be between the Hodgkin lymphoma survivors and race, age, sex, body mass index (BMI) matched control group on frequency of OSA. OSA will be deemed present if either of two conditions is met: (1) polysomnography reveals an apnea hypopnea index (AHI) ≥ 15, or (2) polysomnography reveals an AHI ≥ 5 and the participant presents with clinical symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

HODGKIN LYMPHOMA SURVIVOR ELIGIBILITY CRITERIA

Inclusion Criteria (Hodgkin Lymphoma Survivor):

Current participant in the SJLIFE clinical trial ongoing at St. Jude Children's Research Hospital (SJCRH) and was treated with thoracic radiation for Hodgkin lymphoma
Currently ≥ 18 years of age
≥ 5 years from original diagnosis

Exclusion Criteria (Hodgkin Lymphoma Survivor):

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
History of a neurodevelopmental disorder or birth complication associated with neurocognitive impairment
History of congenital heart disease reported in the literature to be associated with neurocognitive status as determined by the PIs
Currently pregnant
Secondary central nervous system (CNS) neoplasm

COMPARISON GROUP (CONTROL) ELIGIBILITY CRITERIA

Inclusion Criteria (Comparison Group):

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 (Comparison Group):

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
History of a neurodevelopmental disorder or birth complication associated with neurocognitive impairment
History of congenital heart disease reported in the literature to be associated with neurocognitive status as determined by the PIs
Currently pregnant
History of cancer
1st degree relative of a survivor included in the current study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105

Sponsors and Collaborators

St. Jude Children's Research Hospital
National Cancer Institute (NCI)
University of California, San Diego

Investigators

Principal Investigator: Kevin Krull, PhD, St. Jude Children's Research Hospital
Principal Investigator: Belinda Mandrell, PhD, St. Jude Children's Research Hospital