APNEA: Sleep Apnea in Hodgkin Lymphoma Survivors Treated with Radiation to the Chest

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

Category:

Leukemia / Lymphoma

Diseases Treated:

Hodgkin lymphoma

Eligibility Overview:

This is a non-therapeutic clinical trial that is only open to former St. Jude patients, their family members and friends.

Hodgkin lymphoma survivor

  • Current St. Jude LIFE participant, treated with thoracic radiation for Hodgkin lymphoma
  • At least 18 years old
  • At least 5 years from original diagnosis

Comparison group

  • Sibling, parent, relative or friend of a current or former St. Jude patient
  • At least 18 years old
  1. Brief Summary

    While thoracic radiation therapy 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 are also at risk for fatigue and excessive daytime sleepiness. In a small pilot study of 30 long-term survivors of Hodgkin lymphoma, St. Jude researchers determined 14 (47%) met clinical criteria for obstructive sleep apnea, which has been independently linked to other serious health problems. Survivors of Hodgkin lymphoma, 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.

    Long-term survivors in the St. Jude LIFE study who received thoracic radiation therapy for Hodgkin lymphoma when they were children or teenagers will take part in this study. Researchers will examine indices of sleep quality using polysomnography, and associated neurocognitive performance, brain MRI, and structure and strength of neck muscles. A comparison group composed of healthy individuals will also complete the polysomnography, neurocognitive evaluation, and neck MRI and cervical strength testing.

    Primary Objectives

    • To estimate the prevalence of obstructive sleep apnea in adult survivors of Hodgkin lymphoma treated with thoracic radiation therapy, and compare the frequency to community controls matched on age, sex, race and body mass index
    • To identify specific therapeutic factors associated with obstructive sleep apnea in these survivors
    • To identify biomarkers of obstructive sleep apnea in these survivors
    • To examine associations between obstructive sleep apnea and cardiac morbidity and brain integrity in these survivors

    Eligibility Criteria

    Inclusion criteria include:

    Hodgkin lymphoma survivor

    • Current St. Jude LIFE participant, treated with thoracic radiation for Hodgkin lymphoma
    • At least 18 years old
    • At least 5 years from original diagnosis

    Comparison group

    • Sibling, parent, relative or friend of a current or former St. Jude patient
    • At least 18 years old

    Exclusion Criteria include:

    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
    • Pregnant

    Comparison group

    • 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
    • Pregnant
    • History of cancer
    • First degree relative of a survivor in the APNEA study

    Study Design

    Observational, case-control, prospective

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

  2. About this study

    Some patients who receive radiation therapy for cancer develop long-term side effects. These may include damage to the heart and lungs, poor sleep quality and a disorder known as obstructive sleep apnea. People who have this disorder have long pauses in their breathing while they sleep.

    This clinical trial will look at sleep problems in adult survivors of Hodgkin lymphoma who were treated with chest radiation at St. Jude Children’s Research Hospital when they were children or teenagers. Study participants will take part in an overnight sleep study and have other tests to measure heart, lung and brain functions. Researchers will compare the test results of survivors to a separate group of adults who were not treated for cancer.

    Purpose of this clinical trial

    The main goal of this study is to see how common sleep problems are in adults who were treated for Hodgkin lymphoma as children or teenagers. Researchers also want to find out if cancer treatments given to the heart and lungs are connected to obstructive sleep apnea in adult survivors.

    Eligibility overview

    Hodgkin lymphoma survivor

    • Current St. Jude LIFE participant, treated with thoracic radiation for Hodgkin lymphoma
    • At least 18 years old
    • At least 5 years from original diagnosis

    Comparison group

    • Sibling, parent, relative or friend of a current or former St. Jude patient
    • At least 18 years old
  3. APNEA Quick View
    Sponsors St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT03361020
    Trial Start Date January 2018
    Estimated Enrollment 440
    Study Type Observational
    Conditions Hodgkin lymphoma
    Ages At least 18 years old
    Principal investigator Kevin Krull, PhD
    Study Sites St. Jude Children’s Research Hospital 
    For a consultation or to discuss APNEA St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.