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Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors

Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06421987
Enrollment
100
Registered
2024-05-20
Start date
2024-05-06
Completion date
2027-12-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma, Adult

Brief summary

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.

Detailed description

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.

Interventions

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

Sponsors

St. Jude Children's Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Near-Infrared Spectroscopy (NIRS)Baselinea 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

MeasureTime frameDescription
Cardiopulmonary Exercise Testing (CPX)BaselineCardiopulmonary 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.
Pulmonary Function TestingBaselineAs 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: 1. Forced vital capacity (FVC) - measured in liters 2. Forced expiratory volume in 1 second (FEV1) - measured in liters/per second 3. FEV1/FVC ratio - measurement will be a percent. 4. 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.
Neurocognitive OutcomesBaseline\- 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).

Countries

United States

Contacts

CONTACTNicholas Phillips, PhD
referralinfo@stjude.org866-278-5833
PRINCIPAL_INVESTIGATORNicholas Phillips, PhD

St. Jude

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026