Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

For the "10,000 steps" group, participants will be asked to achieve a goal of 10,000 steps a day and to engage in 30 minutes of continuous exercise every day. Steps will be monitored with the under Armour fitness tracker which participants will receive.

For motivation, messages will be sent to study participants in this group via the messaging center in the Under Armor application three times a week. The frequency of messaging will be increased for participants who fail to meet their goals for three consecutive days. Study participants will also receive a weekly call to assess for side effects and provide additional encouragement.

This will be the usual care group. Participants will also receive a fitness tracker to enable monitoring of steps and will be given a flyer that references the ACC/AHA guidelines for exercise and physical activity for the general population. Participants will not receive text messages or phone calls.

Participants will be asked to achieve 10,000 steps daily and to participate in 30 minutes of continuous exercise of their choosing. They will also receive text messages during the week and weekly motivational call

10,000 steps

Participants will receive the ACC/AHA exercise guidelines

Usual Care

Roberta Florido, MD

This research is being done to determine whether exercise while receiving doxorubicin or Adriamycin chemotherapy for breast cancer can reduce the cardio-toxic effects of this treatment on the heart and improve other outcomes related to cancer such as tumor markers, nausea, fatigue and the ability to tolerate chemotherapy.

This will be a pilot study that looks at the effect of exercise, while receiving anthracycline therapy, on mitigating the cardio toxic effects of anthracyclines as assessed by serial echocardiographic strain analysis.

Potential participants will be identified during chart review in advance of a routine clinic visit or during a routine clinic visit with a provider. Individuals will be approached by the provider or study team to determine willingness to learn more about a study for which they may be eligible. Discussions regarding study participation will take place privately and individuals will be provided with the Institutional Review Board (IRB) approved consent form.

In addition, potential participants may contact the study team directly. This contact may be in the form of telephone, email, etc. Initial discussions regarding study participation may take place by phone, email, etc., and individuals may be provided with the IRB approved consent form and other IRB reviewed and approved materials (e.g., Patient Handout), as applicable.

In all cases, as much time as is needed to consider study participation will be allowed to possible participants; resulting in multiple phone calls, visits, emails, or other communication, as necessary. For individuals who choose to take part, informed consent will happen as per the consent process.

Patients will be recruited from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Sibley Memorial Hospital and the community. The investigators anticipate that among roughly 60 subjects approached for enrollment, 30 will be part of the final study. Participants who agree to participate will be asked to provide written consent. Participants will be randomized by an online system to one of the following two groups in a 1:2 ratio. Group 1(Usual care group) will receive a fitness tracker and flyers that reference the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise and physical activity for the general population. In addition to fitness tracker and flyers, Group 2 (10,000 steps group) will receive additional messages and phone calls for motivation. This group of participants will also be asked to take part in 30 minutes of continuous exercise daily as part of their intervention.

For motivation, messages will be sent to study participants in group 2 via the messaging center in the Under Armour application three times a week. With the application, study participant will receive a phone alert and an email message to which they may respond if needed. The frequency of messaging will be increased for participants who fail to meet their goals for three consecutive days. In addition to the Under Armour application, participants will be provided with a log sheet for recording their daily steps, whether 30 minutes of continuous activity daily was completed and the type of the activity done for the 30 minutes. Group two study subjects will also receive a weekly call to assess for side effects and provide additional encouragement. Log sheets will be collected during oncology clinic visits and the aforementioned intervention will be continued for the duration of their chemotherapy treatment. Group 1 study participants will be assessed for side effects through a phone call every 4 weeks.

For the study, women will be given an Under Armour band that will monitor daily steps, amount of sleep and heart rate. Participants will be asked to download the Under Armour application to their mobile phones so the data from their bands can be synced with the application daily. For the intervention, study subjects will be asked to achieve a goal of 10,000 steps a day and to engage in 30 minutes of continuous exercise every day and this can be any form of exercise.

All patients who agree to participate will be invited to the Johns Hopkins Hospital medical campus where all the testing will be performed. The investigators expect to complete the study in 9 months.

Study participants who agree to participate will have the following assessments performed at baseline:

1. A Cardiopulmonary Exercise Stress Test done using the standard protocol and supervised by an exercise physiologist.
2. A 2D echocardiogram. The echocardiogram will include assessment of strain using speckle tracking and tissue Doppler and the determination of systolic ejection time. All patients routinely have an echocardiogram performed prior to the initiation of cardio-toxic chemotherapy such as doxorubicin (Adriamycin), trastuzumab (Herceptin) and pertuzumab (Perjeta), however, for the study, strain analysis will be performed off line on the images obtained during the clinically indicated baseline echocardiogram. Echocardiograms will be performed by experienced sonographers and on the same model echo machine to reduce variability.
3. Bone densitometry assessment via a Dual-energy X-ray absorptiometry to measure total and regional body composition in the frontal plane to determine bone, fat and fat-free mass. The Dual-energy X-ray absorptiometry scan takes about 8-10 minutes. The total radiation dose is approximately 1 millirem, which is very small.
4. Muscle strength will be measured using a hand grip tool.
5. Habitual activity levels will be assessed using the Rapid Assessment of Physical Activity questionnaire, which categorizes activity levels on a scale from 1-7 (sedentary to active).
6. Quality of life will be assessed with the Functional Assessment of Cancer Therapy-Breast survey
7. Fatigue level will be performed with the Multidimensional Fatigue Symptom Inventory-Short Form
8. All patients routinely have blood work collected, and as part of this research protocol, the investigators will also collect blood to determine baseline tumor markers ( high-sensitivity C-reactive protein, Insulin-like growth factor 1, interleukin -6, interleukin-1 and tumor necrosis factor alpha, leptin, adiponectin, estradiol, DNA extraction, lymphocyte telomere length) and cardiac biomarkers (high sensitivity troponin, troponin, pro-brain natriuretic peptide). The investigators will also collect and store blood in order to keep open the possibility of doing a more extensive study to look at any future genes that might be related to the phenotypes in this study (cancer, cardiomyopathy, exercise response, etc.).
9. Cardiac history will be obtained at recruitment, including clinical risk factors for heart disease (hypertension, diabetes and smoking history) and participants will be evaluated throughout the study for any cardiac symptoms especially those of Heart failure.

All of the above assessments will all be performed at baseline and repeated within 2 weeks of the women completing their anthracycline-based chemotherapy. The investigators will also track the clinical echocardiograms obtained at 12 months, but these results are not required for the study.

Other studies: Serum troponin levels will be checked with each cycle of chemotherapy. Height will be measured upon recruitment and weight and blood pressure will be measured at the time of each echocardiogram.

Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer.

Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer Who Will be Treated With Anthracyclines

Development of left ventricular dysfunction, assessed by echocardiogram and defined as a decrease in global longitudinal strain between the baseline echocardiogram and the echocardiogram obtained post-treatment with an anthracycline.

Cardiorespiratory fitness/peak oxygen consumption measured using a metabolic stress test

Dual-energy x-ray absorptiometry scan will be performed using standard procedures

Functional Assessment of Cancer Therapy-Breast survey will be administered upon completion of therapy to assess for change in quality of life. Each question on the questionnaire ranges from 0 to 4. The least score is 0 and the maximum is 148 points. Higher scores indicate a higher quality of life.

Change in physical activity with the intervention will be assessed by the Rapid Assessment of Physical Activity questionnaire. This is scored from 1 to 7 with 7 being the most active.

Multidimensional Fatigue Symptom Inventory-Short Form will be used to assess for change in fatigue. Scores for each question range from 0 to 4. The maximum total fatigue score is 72. The higher the score, the more fatigued one is.

Analysis will be performed to assess the impact that receiving motivational text messages has on increasing the amount of physical activity performed/number of daily steps achieved.

Analysis will be performed to assess the impact of weekly telephone calls on increasing the amount of physical activity/number of daily steps achieved

Analysis will be performed to assess the impact that engaging in 30 minutes of daily exercise has on increasing the amount of physical activity performed/number of daily steps achieved

Difference in troponin levels in the the two groups post treatment

Johns Hopkins University

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Cardiotoxicity

Exanthema

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

subjects with heart failure, coronary artery disease, valvular heart disease, arrhythmia, hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension and pericardial disease after hematopoietic stem cell transplantation.

subjects with on heart failure, coronary artery disease, valvular heart disease, arrhythmia, hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension and pericardial disease after hematopoietic stem cell transplantation.

MU Kai

ZHANG Jing

MU Kai, Doctor

Hematopoietic stem cell transplantation is an important method for the treatment of hematological diseases and cyclophosphamide is a commonly used chemotherapeutic agent for transplant pretreatment. The incidence of severe cardiovascular events after high-dose cyclophosphamide exposure ranges from 7% to 28% with mortality from 11% to 43%. Thus, an non-invasive, sensitive and reliable method in detecting cardiac function is significant to balance the cardiac risk and the potential cancer treatment benefits. In previous studies, we demonstrated that strain values analyzed by speckle tracking echocardiography decreased significantly after high-dose cyclophosphamide exposure, even though left ventricular ejection fraction remained stable and within normal range. We follow up the hematopoietic cell transplantation patients with cyclophosphamide: to analyze the cut-off values of the parameters of speckle tracking multilayer analysis in predicting early cardiotoxicity induced by cyclophosphamide; to detect the cut-off values of the plasma miRNAs levels in predicting early cardiotoxicity induced by anthracycline.

The purpose of our study is to find out non-invasive, reliable and sensitive echocardiographic parameters and plasma biomarkers for early detection and prediction cyclophosphamide -induced cardiac toxicity and to be helpful to target patients at high risk of cardiotoxicity, who could benefit from closer monitoring or earlier initiation of cardioprotective therapy.

After obtaining the informed consent of the research subjects, collect the following data of the research subjects: demographic information, clinical symptoms, family history and clinical diagnosis. Patients were tested for troponin, atrial natriuretic peptide, concurrent conventional electrocardiogram, conventional echocardiogram, speckle tracking echocardiography at spots 1 day before cyclophosphamide treatment, 2 days after cyclophosphamide infusion, and 10 days after cyclophosphamide infusion. ethylenediaminetetraacetic acid anticoagulated whole blood were saved and extract the blood cells from the sample bank and freeze them for RNA sequencing. The two-dimensional cardiac ultrasound image acquisition complies with the guidelines of the American Echocardiography Association, and the two-dimensional speckle tracking echocardiography acquisition is 4 cardiac cycles. If a cardiotoxic event occurs during this period, an electrocardiogram, conventional echocardiogram, and speckle tracking echocardiography should be performed within 24 hours.

Analyze the correlation between miRNA and clinical events of cardiotoxicity, and evaluate the predictive threshold of cardiotoxicity in children with high-dose cyclophosphamide chemotherapy.Evaluate the weight of miRNA in predicting cardiac damage, combined with serum biomarkers, construct a model for Predicting the risk of myocardial damage based on speckle tracking echocardiography parameters, serum biomarkers, and miRNA expression.

Early Identification and Evaluation of Cyclophosphamide Cardiotoxicity

Early Identification and Evaluation of the Cardiotoxicity of Cyclophosphamide in Hematopoietic Stem Cell Transplantation : Based on Spot Tracking Ultrasound

changes of global longitudinal strain value between cardiotoxicity group and No cardiotoxicity at the follow-up point

changes of miRNA between cardiotoxicity group and No cardiotoxicity

Kai Mu

Clinical Research Assistant

Rare Diseases

Pheochromocytoma

Paraganglioma

Cardiomyopathies

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

Vasoconstrictor Agents

Respiratory System Agents

Antihypertensive Agents

Epinephrine

Racepinephrine

Epinephryl borate

Patients included in this cohort (n=50) are those who are diagnosed of Pheochromocytoma / Paraganglioma, willing to consent for the study and not on α-blockade at the time of recruitment into study, while can be on any other anti hypertensives

Patients in this group, besides the usual evaluation of Pheochromocytoma / Paraganglioma, will also undergo detailed cardiac and vascular evaluation, which will be done at diagnosis, at 7- 10 days of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision The cardiovascular evaluation includes 2D-echocardiography, speckle tracking Echo (for measuring global longitudinal strain), serum NT-proBNP estimation and flow mediated vasodilatory studies by Doppler Ultrasonography of the brachial artery to assess the endothelial dependent and smooth muscle dependent vasodilatory responses

This is a contemporary age- and gender-matched control group This group includes 10 newly detected (within 3 months) Essential Hypertensive patients, who will undergo treatment with standard anti- HT medications Cardiac evaluation will be done at baseline and after 3 months of anti hypertensive medications

This is a contemporary age- and gender-matched control group This group includes 10 Healthy individuals (normal in physical examination, ECG , Echo), that include hospital staff nurses, technicians, doctors whom would be requested to volunteer Cardiac evaluation will be done at the start of study and after 6 months

Observational study

Gaurav Agarwal, MS,DNB,PDC

PHEOCHROMOCYTOMA (PCC)/ PARAGANGLIOMA are catecholamine secreting tumors with varied manifestations. Besides hypertension, PCC patients may have subclinical to overt cardiac and vascular dysfunction, which are important to recognize to minimize perioperative morbidity and mortality. Cardiovascular (CV) dysfunction can be in the form of hypertension, left ventricular (LV) hypertrophy, heart failure, cardiomyopathy, dysrhythmias, angina and Myocardial infarction. Literature search revealed a few retrospective and a few prospective studies, including one prospective follow up study conducted at SGPGIMS to document CV changes in PCC. Our institutional study was the first to document the nature and extent of CV dysfunction and cardiomyopathy and their reversal after surgical cure. The studies revealed that PCC patients had significantly higher LV mass index, higher LV diastolic dysfunction, subclinical impaired LV systolic function. Earlier studies postulated apparent improvement in various cardiac indices even with selective α-blockade and continued after surgical cure, with near normalization at 3 -6 months postoperatively. Detailed cardiac and vascular evaluation in PCC patients can be of help in preoperative optimization of cardiac risk and may provide prognostic information The literature on PCC-mediated CV dysfunction and catecholamine cardiomyopathy is largely limited to case reports and retrospective studies, with few reports of their reversal after curative PCC operations. Whether the duration of disease influence the function of heart was not apparently addressed in earlier trials. Trials that established the differences in the degree of cardiac dysfunction between normotensive and hypertensive PCC patients involved smaller proportion of study subjects. Sub clinical changes in endomyocardium was presumed but not objectively assessed and hence its reversal after surgical cure is uncertain.

The aim of this research is to study the cardiac and vascular changes in Pheochromocytoma/ Paraganglioma patients and their reversal following curative surgery

The aim of this research is to study the cardiac and vascular changes in Pheochromocytoma/ Paraganglioma patients and their reversal following curative surgery

This prospective, case-control study is conducted at SGPGIMS, Lucknow, India, tertiary care referral institute, between January 2019 and September 2021 after approval from institutional ethics committee. The study group includes 50 biochemically and histopathology proven PCC /Paraganglioma patients, who after 1 to 3 weeks of α-adrenoceptor blockade with oral prazosin undergo primary laparoscopic or open surgery. Cure of hypercatecholaminism will be documented by normal 24-hour urinary fractionated metanephrine values at 7-10 days postoperatively.

Two contemporary age- and gender-matched control groups includes 10 newly detected (withtin 3 months) Essential Hypertensive (E-HT) patients, who will undergo treatment with standard anti- HT medications and 10 Healthy individuals (normal in physical examination, ECG , Echo), that include hospital staff nurses, technicians, doctors whom would be requested to volunteer.

METHODOLOGY

Patients in the study group, besides the usual evaluation of PCC, also undergo detailed cardiac and vascular evaluation, at diagnosis, at 7- 10 days of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision and in control groups - E-HT controls, cardiac evaluation is done at diagnosis and after 3 months of anti HT medications ; in Healthy individuals, cardiac evaluation is done at the start of study and after 6 months.

The CV evaluation includes 2D-echocardiography, speckle tracking Echo (for measuring global longitudinal strain), serum NT-proBNP estimation and flow mediated vasodilatory studies by Doppler Ultrasonography of the brachial artery to assess the endothelial dependent and smooth muscle dependent vasodilatory responses

Cardiac and Vascular Changes in Pheochromocytoma and Paraganglioma

Prospective Cohort Study of Objective Cardiac and Vascular Changes in Pheochromocytoma and Paraganglioma and Their Reversal Following Curative Surgery

Left ventricle end systolic and end diastolic diameter in millimeter

Left ventricle end systolic and end diastolic volume dimensions in milliliter

Left ventricle Ejection fraction by Simpsons method in percentage

Peak velocities of the early (E) and Late phase (A) of the mitral valve inflow pattern and their ratio in centimeter per second

Flow rate across mitral valve in centimeter per second and deceleration time in millisecond

Left ventricle global longitudinal strain in percentage

Left ventricle global circumferential strain in percentage

Flow mediated dilation of brachial artery diameter pre and post sublingual isosorbide dinitrate in millimeter

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer.	NCT03027063	Breast Cancer F... Adriamycin Toxi...	10,000 steps Usual Care	18 Years -	Johns Hopkins University
Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer.	NCT03027063	Breast Cancer F... Adriamycin Toxi...	10,000 steps Usual Care	18 Years -	Johns Hopkins University
Early Identification and Evaluation of Cyclophosphamide Cardiotoxicity	NCT05150080	Cardio-oncology Hematopoietic S... Cardiotoxicity Cyclophosphamid... Echocardiograph...		- 14 Years	Qianfoshan Hospital
Cardiac and Vascular Changes in Pheochromocytoma and Paraganglioma	NCT05082311	Pheochromocytom... Paraganglioma Cardiovascular ...	Observational s...	7 Years -	Sanjay Gandhi Postgraduate Institute of Medical Sciences
Early Identification and Evaluation of Cyclophosphamide Cardiotoxicity	NCT05150080	Cardio-oncology Hematopoietic S... Cardiotoxicity Cyclophosphamid... Echocardiograph...		- 14 Years	Qianfoshan Hospital

Spots Global Cancer Trial Database for speckle tracking echocardiography