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

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ClinicalTrials.gov Identifier: NCT03361020
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : January 25, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of California, San Diego
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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:

  1. 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.
  2. To identify specific therapeutic factors associated with OSA in adult survivors of HL treated with thoracic radiation.
  3. To identify biomarkers of OSA in adult survivors of HL treated with thoracic radiation.
  4. To examine associations between OSA and cardiac morbidity and brain integrity in the adult survivors of HL treated with thoracic radiation.

Condition or disease
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.


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Study Type : Observational
Estimated 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 : January 23, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023


Group/Cohort
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.



Primary Outcome Measures :
  1. Number of participants with obstructive sleep apnea (OSA) compared between groups [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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. 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361020


Contacts
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Contact: Kevin Krull, PhD 866-278-5833 referralinfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Kevin Krull, PhD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Kevin Krull, PhD         
Principal Investigator: Belinda Mandrell, PhD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
University of California, San Diego
Investigators
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Principal Investigator: Kevin Krull, PhD St. Jude Children's Research Hospital
Principal Investigator: Belinda Mandrell, PhD St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT03361020     History of Changes
Other Study ID Numbers: APNEA
R01CA215405 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases