Clinical trial NCT06421987: Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors
Official title: Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hodgkin Lymphoma, Adult
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Near-Infrared Spectroscopy (NIRS)
timeFrame: Baseline
Secondary outcomes:
measure: Cardiopulmonary Exercise Testing (CPX)
timeFrame: Baseline
measure: Pulmonary Function Testing
timeFrame: Baseline
measure: Neurocognitive Outcomes
timeFrame: Baseline
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude
name: Nicholas Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References: