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NCT Number: NCT06421987

Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors

SURVIVORS

Study participants are being asked to take part in this research study called HODNIRS because the participant is a survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital. The study is being done to help investigators understand the link between long term effects of chest radiation and bleomycin for HL and brain function in survivors.

Primary Objective To evaluate dynamic changes in CBF and oxygenation during exercise with Near Infrared Spectroscopy (NIRS) in HL survivors and non-cancer controls matched for age, sex, race, and ethnicity. .

Secondary Objectives To examine the degree of CO2 clearance (DLCO/ETCO2) during rest and exercise in Hodgkin Lymphoma (HL) survivors compared to non-cancer controls matched for age, sex, race, and ethnicity.

CONTROLS

Volunteers are being asked to take part in this research study because they are non-first degree relative or friend of someone who received treatment for a childhood cancer or similar illness at St. Jude Children's Research Hospital or are an employee/affiliate of St. Jude Children's Research Hospital and have agreed to be a St. Jude Life Cohort Study (SJLIFE) community control.

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Key information

Conditions

Hodgkin Lymphoma, Adult Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location status: Recruiting

Location contact

Nicholas Phillips, PhD

CONTACT

[email protected]

888-226-4343

Nicholas Phillips, PhD

PRINCIPAL_INVESTIGATOR

About this study

NIRS is a portable, non-invasive, brain imaging device that uses low levels of non-ionizing light to record variations in blood flow in the brain. The NIRS is wearable and can read blood flow to the brain during physical activity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HL Survivors

  • Completed bleomycin and/or thoracic radiation therapy for HL at SJCRH.
  • <21-years old at diagnosis; currently ≥18-years of age and ≥2-years post therapy.
  • SJLIFE or ACT/SJLIFE participants
  • English language proficiency.

Community Controls

  • SJLIFE control.
  • ≥18-years of age at the time of enrollment with age sampling to broadly match the HL survivors.

Exclusion criteria

HL Survivors

  • History of cranial or total-body irradiation therapy.
  • History of intrathecal or high dose intravenous antimetabolite therapy.
  • History of head injury or diagnosis of a genetic disorder associated with cognitive impairment.

Treatment and study plan

Near Infrared Spectroscopy (NIRS)

Device

NIRS is a portable, non-invasive, brain imaging device.

Primary outcomes

  1. Near-Infrared Spectroscopy (NIRS)

    Time frame: Baseline

    a non-invasive imaging technology that is used to measure regional or global cerebral tissue oxygenation and cerebral blood flow (CBF) during exercise. NIRS takes advantage of the fact that oxygenated blood and de-oxygenated blood absorb light differently. By measuring the reflected light from blood, the concentration of both oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (HbdO2) using the modified Beer-Lambert Law can be calculated.

Secondary outcomes

  1. Cardiopulmonary Exercise Testing (CPX)

    Time frame: Baseline

    Cardiopulmonary Exercise Testing (CPX) will be performed with the goal of maximal exertion. Participants are monitored with 12-lead electrocardiogram (ECG) and serial blood pressure measurements during and after exercise, and during recovery. Study participants whose physical performance does not permit walking safely on the treadmill, will perform CPX on a bicycle or upper extremity ergometer using a comparable testing protocol.

    Oxygen consumption during CPX- Oxygen will be measured at baseline and continuously during CPX. Total minute ventilation (respiratory rate X tidal volume; l/min), and ventilatory reserve (l/min) will be used to assess the ability of the pulmonary system to respond to exercise.

  2. Pulmonary Function Testing

    Time frame: Baseline

    As part of the St. Jude Life (SJLIFE) study visit, participants will complete PFT's performed in a single laboratory according to the American Thoracic Society Task Force Guidelines. Pulmonary Function Tests (PFTs) will include:

    • Forced vital capacity (FVC) - measured in liters
    • Forced expiratory volume in 1 second (FEV1) - measured in liters/per second
    • FEV1/FVC ratio - measurement will be a percent.
    • DLCO capacity of lung to transfer carbon monoxide - measured in mL/min/mm Hg.

    These measurements will be compared with those predicted for the participant's age, race, sex, and height.

  3. Neurocognitive Outcomes

    Time frame: Baseline

    • As part of the SJLIFE study visit, participants will complete neurocognitive testing (Wechsler Abbreviated Scale of Intelligence; Connors Continuous Performance; California Verbal Learning; Coding Digital Symbol; Grooved Pegboard; Trail Making; Verbal Fluence; Visual Selective; Digital Span; and Rey Complex). All tests are converted to z-scores (1.0 z-score is 1 standard deviation lower than the mean).

Study contacts

Contact information is provided by the study sponsor or research team.

Nicholas Phillips, PhD

CONTACT

[email protected]

888-226-4343

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 20, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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