Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Substance Related Disorders

Heart and Blood Diseases

Symptoms and General Pathology

Wounds and Injuries

Prostatic Neoplasms

Drug-Related Side Effects and Adverse Reactions

Cardiotoxicity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Heart Diseases

Chemically-Induced Disorders

Radiation Injuries

All Drugs and Chemicals

Androgens

We will perform detailed phenotyping of Social Determinants of Health using the National Institute of Minority Health and Health Disparities PhenX SDOH toolkit at baseline.

Social Determinants of Health

Bonnie Ky, MD, MSCE

Amanda Smith, MA

This is an observational study for patients with prostate cancer that will be treated with Androgen Deprivation Therapy. The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 5 years.

The investigators propose a prospective longitudinal cohort of prostate cancer patients treated with Androgen Deprivation Therapy (ADT) to determine the associations between social determinants of health (SDOH) and cardiotoxicity risk and to determine wither associations between SDOH and cardiotoxicity risk differs according to race. Patients will be followed with serial echo, blood draw, and surveys prior to start of ADT and then 6 months, 1 year, 2 years, 3 years, and 5 years after start of ADT.

Plasma, Serum, and buffy coat will be banked.

Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer

Cardiotoxicity of Prostate Cancer Therapy: Mechanisms, Predictors, and Social Determinants of Health in Prostate Cancer Patients Treated With Androgen Deprivation Therapy

Absolute change in LVEF by echocardiogram at follow-up

Incidence of CTRCD defined as at least a 10% absolute change in LVEF by echocardiogram at follow-up relative to baseline to a value \< 50%

Incidence of symptomatic heart failure (centrally adjudicated)

Change in longitudinal strain by echo from baseline

Change in circumferential strain by echo from baseline

Change in diastolic function defined as E/e' by echo from baseline

Change in relative LV wall thickness from baseline

Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline

Change in LV Twist measured by 3D echo from baseline

Change in LV Torsion measured by 3D echo from baseline

Change in NTproBNP measured in batches from banked samples from baseline.

Change in hs-TnT measured in batches from banked samples from baseline.

Change in Patient Reported Outcomes Information System (PROMIS) Fatigue Score from baseline. A higher score corresponds to higher reported levels of fatigue.

Change in Patient Reported Outcomes Information System (PROMIS) Global Health score from baseline. Higher scores indicate a healthier patient.

Change in total weekly leisure activity in METS assessed by Godin Leisure Time Exercise Questionnaire from baseline.

American Heart Association

Abramson Cancer Center at Penn Medicine

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Heart Failure

Breast Neoplasms

Lymphoma

Cardiomyopathies

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Breast Diseases

Skin Diseases

Lymphosarcoma

NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months.

Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.

NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.

NTproBNP above the upper limit of normal will trigger the initiation of heart failure therapy with counseling from a study investigator based on protocol specified algorithm.

Biomarker Guided Intervention

Investigators will evaluate the safety and feasibility of a biomarker-guided cardioprotection strategy using NTproBNP, as compared to usual care, in breast cancer and lymphoma patients treated with anthracyclines.

This is a randomized, open-label pilot trial of a biomarker-guided strategy using NT-proBNP to identify and treat patients with a high risk of cancer therapy-related cardiotoxicity. Patients will be enrolled and randomized prior to initiation of anthracycline-based therapy and followed for 12 months with blood samples, echocardiography, and patient reported outcomes surveys. The overall hypothesis is that a biomarker guided treatment strategy that initiates neurohormonal antagonists in breast cancer or lymphoma patients who have increases in NT-proBNP prior to, during, or after anthracyclines will be feasible, well-tolerated, and result in attenuation of cardiotoxicity, compared to standard care.

Serial monitoring of NTproBNP during chemotherapy will be used to identify high-risk patients in the intervention arm; patients who experience elevations in NTproBNP will be initiated and titrated on a personalized regimen of neurohormonal antagonists. Patients in the usual care arm will not have serial NTproBNP monitoring and will be managed according to usual care.

Pilot Study of an NTproBNP Guided Strategy of Cardioprotection

A Randomized, Open Label Pilot Trial of a Biomarker Guided Strategy of Cardioprotection in Patients With Lymphoma or Breast Cancer Treated With Anthracyclines

Change in global longitudinal strain by echocardiogram

Change in circumferential strain by echocardiogram

Change in hsTnT measured in batches from banked samples

Change in GDF-15 measured in batches from banked samples

Change in MPO measured in batches from banked samples

Change in NTproBNP measured in batches from banked samples for all patients on both arms

Change in total weekly leisure activity in METS (assessed by GODIN Leisure Time Exercise Questionnaire)

Change in MD Anderson Symptoms Inventory - Heart Failure (MDASI-HF). Higher scores indicate increased symptom severity or symptom distress.

Change in Patient Reported Outomes Information System (PROMIS) Fatigue Score. A higher score corresponds to higher levels of reported fatigue.

Change in Patient Reported Outomes Information System (PROMIS) Global Health score. Higher scores indicate a healthier patient.

Change in NCI Patient Reported Outcomes - Common Terms and Criteria for Adverse Events (PRO CTCAE).

Incidence of anthracycline chemotherapy being held or discontinued secondary to side effects or toxicity

percent of eligible patients who are randomized

percent of randomized patients who complete the study per protocol

percent of study activities completed in window

Compliance by PROMIS Scale v1.0 for patients in the biomarker guided arm initiated on heart failure medications

Maximum tolerated dosage of neurohormonal antagonist medications for patients in the biomarker-guided arm with NTproBNP above upper limit of normal

Rate of Grade 2 or higher adverse events by CTCAEv5.0

Change in clinically measured NTproBNP following initiation of neurohormonal antagonists in patients with NTproBNP above upper limit of normal in the biomarker guided arm

Change in core-lab quantitated left ventricular ejection fraction

Incidence of cardiotoxicity defined as LVEF decline of at least 10% to less than 50%

Incidence of new or worsened clinical heart failure, defined as urgent or new office or emergency department visit or hospitalization for HF, adjudicated by a clinical events committee

Frequency of cancer treatment interruptions due to cardiotoxicity

National Heart, Lung, and Blood Institute (NHLBI)

Antineoplastic Agents

Trastuzumab

Doxorubicin

Liposomal doxorubicin

Patients treated with doxorubicin (Adriamycin) for breast cancer

Patients treated with trastuzumab (Herceptin) for breast cancer

Patients treated with both doxorubicin (Adriamycin) and trastuzumab (Herceptin) for breast cancer

The study will perform detailed phenotyping of Social Determinants of Health using the National Institute of Minority Health and Health Disparities PhenX SDOH toolkit at baseline.

This is an observational study for patients with breast cancer that will be treated with doxorubicin (Adriamycin) and/or trastuzumab (Herceptin). The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 15 years.

The investigators propose a prospective longitudinal cohort of breast cancer patients treated with anthracyclines and/or trastuzumab to determine the associations between social determinants of health (SDOH) and cardiotoxicity risk and to determine whether associations between SDOH and cardiotoxicity risk differ according to race. Patients will be followed with serial echo, blood draw, and surveys every 3 months for the first year, then annually for two years. After 3 years following start of cancer therapy, patients will have study visits every other year for up to 15 years.

Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer

Cardiotoxicity of Cancer Therapy 2: Mechanisms, Predictors, and Social Determinants of Health in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer	NCT05096338	Prostate Cancer Cardiotoxicity Drug-Related Si... Cardiovascular ...	Social Determin...	18 Years -	Abramson Cancer Center at Penn Medicine
Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer	NCT05096338	Prostate Cancer Cardiotoxicity Drug-Related Si... Cardiovascular ...	Social Determin...	18 Years -	Abramson Cancer Center at Penn Medicine
Pilot Study of an NTproBNP Guided Strategy of Cardioprotection	NCT04737265	Cardiotoxicity Toxicity Due to... Breast Cancer Lymphoma Cardiomyopathie... Heart Failure	Biomarker Guide...	18 Years -	Abramson Cancer Center at Penn Medicine
Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer	NCT05078190	Breast Cancer Cardiotoxicity Drug-Related Si... Cardiovascular ...	Social Determin...	18 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for cardiotoxicity of chemotherapy