Hodgkin Lymphoma, AdultNCT06421987
Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors
An observational study of Hodgkin Lymphoma, Adult, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hodgkin Lymphoma, Adult
- What is being tested?
- Near Infrared Spectroscopy (NIRS)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2024to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Nicholas Phillips, PhD, 888-226-4343, referralinfo@stjude.org
Nicholas Phillips, PhD
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Hodgkin Lymphoma, Adult
- Being tested
- Near Infrared Spectroscopy (NIRS)
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Spectroscopy (NIRS)Device
NIRS is a portable, non-invasive, brain imaging device.
| Study group | Role | What they receive |
|---|---|---|
| SURVIVOR | A survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital.
and Control: Voluntarily taking part in this study because you are a relative, friend or employee of St. Jude Children's Research Hospital. Receives: Device: Near Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Baseline
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.
Measured: Baseline
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start6 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin Lymphoma, AdultStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Phillips, PhD, Principal investigator, St. Jude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421987
- Sponsor's protocol ID
- HODNIRS
- Other IDs
- NCI-2024-03932
- Status last verified
- Aug 2026
- First submitted
- 1 May 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No