Cardiac Screening for Hodgkin's Lymphoma Survivors

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Age < 15, Relapse < 1 year, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a heart health screening program can be implemented for Hodgkin's lymphoma survivors. It will identify heart risk factors that might be adjusted with lifestyle changes or medication and check for any serious heart issues that might require treatment. The study will also examine whether heart health affects overall quality of life. It is suitable for those treated for Hodgkin's at Brigham and Women's Hospital or Dana-Farber Cancer Institute, who have been cancer-free for over a year and completed treatment at least five years ago. Participants will meet with a cardiologist and undergo heart tests, such as an echocardiogram (which uses sound waves to produce images of the heart) and a stress echo (a heart test during physical activity). As an unphased trial, this study offers a unique opportunity to contribute to important research that could improve heart health screening for cancer survivors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this cardiac screening protocol is safe?

Research has shown that heart screening methods like echocardiograms (heart ultrasound) and stress echocardiograms (heart ultrasound during exercise) are generally safe. These non-invasive tests do not require cuts or needles, and most people tolerate them well. No reports of serious side effects have emerged from these tests. Survivors of Hodgkin's lymphoma often need regular heart check-ups due to a higher risk of heart problems. These tests help monitor heart health without adding extra risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this cardiac screening protocol for Hodgkin's Lymphoma survivors because it emphasizes early detection of cardiac issues, which is often overlooked in standard follow-up care. Unlike traditional monitoring, which may not include comprehensive heart assessments, this approach uses both resting and stress echocardiograms to thoroughly evaluate heart health. By identifying cardiac risk factors early, this protocol has the potential to prevent severe heart problems, improving long-term health outcomes for survivors.

What evidence suggests that this cardiac screening program is effective for Hodgkin's lymphoma survivors?

Research has shown that heart ultrasounds and stress tests can detect heart problems in Hodgkin's lymphoma survivors. In this trial, participants will undergo cardiac screening, which includes consultations with a study cardiologist and both resting and stress echocardiograms. These tests can identify heart risks manageable through lifestyle changes or medication. Reviews of studies recommend regular heart check-ups for survivors, especially beginning ten years after treatment, to catch heart issues early. These screenings aim to improve long-term heart health and quality of life by ensuring quick detection and treatment of heart problems. ^{4 6 7 8 9}

Who Is on the Research Team?

Andrea K. Ng

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for survivors of Hodgkin's disease who were treated with chest radiation at Brigham and Women's Hospital or Dana-Farber Cancer Institute, are over 15 years old, have been in remission for more than a year, and it has been five or more years since their initial treatment.

Inclusion Criteria

I have been free from cancer for more than a year.

I received treatment for Hodgkin's disease with chest radiation at Brigham and Women's Hospital or Dana-Farber Cancer Institute.

I am 15 years old or older.

Exclusion Criteria

My condition worsened within a year of treatment.

Patients treated for Hodgkin's disease outside of Brigham and Women's Hospital or Dana-Farber Cancer Institute

Less than 5 years out from initial treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Cardiac Screening

Participants meet with a study cardiologist and undergo cardiac risk factors screening, resting and stress echocardiogram

1 day

1 visit (in-person)

Follow-up

Participants are monitored for cardiac health and quality of life, with repeat screenings every 18 months to 3 years depending on time since initial treatment

3 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Echo/Stress Echo

Trial Overview The study aims to establish a heart screening program for Hodgkin's disease survivors. It involves checking the heart using echo/stress echo tests to identify potential risks and improve quality of life through lifestyle changes or medication if needed.

How Is the Trial Designed?

Group I: Cardiac screening Experimental Treatment 1 Intervention

Interventions: Participants will * meet with study cardiologist * undergo cardiac risk factors screening * undergo resting and stress echocardiogram (echo and stress echo)

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

A study involving 191 childhood cancer survivors showed that the handheld mHealth platform (Vivio) accurately assessed cardiac function, with results closely matching those from cardiac magnetic resonance imaging (CMR), indicating its potential for effective real-time monitoring.

In contrast, traditional echocardiography significantly overestimated left ventricular ejection fraction (EF) and had poor sensitivity for detecting cardiac dysfunction, highlighting the advantages of using Vivio for better identification of at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a Novel Handheld Wireless Platform for Detection of Cardiac Dysfunction in Anthracycline-Exposed Survivors of Childhood Cancer. Armenian, SH., Rinderknecht, D., Au, K., et al.[2019]

In a study of 77 childhood cancer survivors (CCSs) who were at least 1 year post-chemotherapy, the prevalence of abnormal left ventricular global longitudinal strain (GLS) increased with exercise stress, indicating some CCSs may have impaired cardiac adaptation during physical activity.

Despite the increased prevalence of abnormal GLS under stress, CCSs showed similar average GLS and strain values compared to healthy controls, suggesting that significant cardiac dysfunction may not be evident early after treatment, particularly in those treated with high-dose anthracyclines or diagnosed before age 5.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Ventricular Strain Analysis During Submaximal Semisupine Bicycle Exercise Stress Echocardiography in Childhood Cancer Survivors. von Scheidt, F., Pleyer, C., Kiesler, V., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030573721000215X

Screening Hodgkin lymphoma survivors for radiotherapy ... The aim of this review is to summarize the available data on different screening modalities for cardiovascular disease and to suggest a screening program.

2. patlynk.com patlynk.com/trial/NCT00165425

Cardiac Screening in Survivors of Hodgkin's Disease ... The main purpose of this study is to determine if it is possible to put into practice a cardiac screening program for survivors of Hodgkin's disease.

3. withpower.com withpower.com/trial/phase-hodgkin-disease-1-2004-0d368

Cardiac Screening for Hodgkin's Lymphoma Survivors The main purpose of this study is to determine if it is possible to put into practice a cardiac screening program for survivors of Hodgkin's disease.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8750391/

A Systematic Review by the Fondazione Italiana Linfomi The USA guidelines focus on a strict control of cardiovascular risk factors, while in cHL survivors an echocardiographic examination is suggested at 10-year ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3749088/

Increasing Rates of Breast Cancer and Cardiac ... At six months, 41% of survivors reported having completed the recommended mammogram; 20% reported having an echocardiogram (females 30%, males 10%). Only 29% of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4221540/

Coronary Artery Disease Detected by ... Hodgkin lymphoma (HL) survivors have significant cardiovascular risk and require long-term surveillance. This study assessed the prevalence of coronary ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2016.70.5400

Prevention and Monitoring of Cardiac Dysfunction in ... A recent population-based cohort study with a median follow-up of 20 years reported a 4.5-fold risk of HF as a first event in survivors of ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.021686

Radiation‐Induced Cardiovascular Disease: Review of an ... A case‐control study of 91 Hodgkin's lymphoma survivors found a 3‐fold increase in risk of cardiomyopathy in patients who received both ...

9. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/382/502361/Treatment-Patterns-and-Outcomes-for-Patients-with

Treatment Patterns and Outcomes for Patients with Classic ... Treatment patterns and outcomes for patients with classic Hodgkin lymphoma (cHL) and cardiomyopathy with low ejection fraction (EF): real-world evidence (RWE) ...