Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors

Hodgkin Lymphoma, Adult Clinical Trial

Official title:

Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06421987
• Other study ID #: HODNIRS
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: March 2027

Study information

• Verified date: May 2024
• Source: St. Jude Children's Research Hospital
• Contact: Nicholas Phillips, PhD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma, Adult
• Lymphoma

Intervention

Device:
• Near Infrared Spectroscopy (NIRS)
NIRS is a portable, non-invasive, brain imaging device.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near-Infrared Spectroscopy (NIRS)	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.	Baseline
Secondary	Cardiopulmonary Exercise Testing (CPX)	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.	Baseline
Secondary	Pulmonary Function Testing	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.	Baseline
Secondary	Neurocognitive Outcomes	- 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).	Baseline

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital