The Effects of Two Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies
- Conditions
- Breast CancerCardiotoxicityCardiovascular Diseases
- Interventions
- Behavioral: High Intensity Interval ExerciseBehavioral: Moderate Intensity Walking
- Registration Number
- NCT05786014
- Lead Sponsor
- University of Virginia
- Brief Summary
The purpose of this study is to determine if exercise preconditioning can mitigate the off target effects of chemotherapy treatment on measures of cardiovascular function, inflammatory responses, and quality of life.
- Detailed Description
Breast cancer is the most common malignancy affecting women in the US and survivors experience long-term health effects of chemotherapy. Exercise training is an efficacious treatment for preserving functional capacity and has shown promise in mitigating cardiac toxicity of breast cancer chemotherapy. However, supervised exercise is not a practical solution for all breast cancer survivors, as medically monitored exercise facilities are poorly dispersed in the US and poorly utilized by cancer patients. To improve reach of these programs, remotely monitoring exercise sessions may be necessary. However, effects of remotely-monitored exercise conditioning before and during adjuvant/neoadjuvant chemotherapy on cardiotoxic outcomes are unknown. Our study aims to address this gap by testing the feasibility of two types of remotely-monitored exercise interventions, an exercise bicycle intervention compared to a brisk walking intervention, in 20 UVA Breast Cancer Clinic patients undergoing cardiotoxic chemotherapies. Remotely-monitored exercise training will start one week prior to chemotherapy (preconditioning) and continue throughout adjuvant or neoadjuvant chemotherapy (which is typically 4 months in duration). Our multidisciplinary research team proposes four aims: 1) Determine the extent to which eligible patients can be successfully recruited, randomized, and retained; 2) Assess VO2peak, echocardiography derived left ventricular ejection fraction and left ventricular global longitudinal strain among these patients at baseline and at \~4 months; 3) Examine treatment engagement and intervention acceptability; and 4) Explore the relationship between engagement in the exercise training and psychosocial function.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 25
- Age 18 years or over
- diagnosis of breast cancer (Stage I-III or IV with minimal burden) and prescribed chemotherapy (TC (Docetaxel/Cyclophosphamide), AC (Doxorubicin/Cyclophosphamide followed by Paclitaxel), TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab), TCH (Docetaxel/Carboplatin/Trastuzumab) with or without Pembrolizumab)
- Physician clearance for exercise training
- Speak/understand English
- previous treatment with cardiotoxic chemotherapy
- medical/orthopedic comorbidities that preclude stationary cycling
- significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
- unstable angina or myocardial infarction within 4-weeks prior to treatment
- complex ventricular arrhythmias or New York Heart Association class IV symptoms
- symptomatic severe aortic stenosis
- acute pulmonary embolus
- acute myocarditis
- History of untreated high-risk proliferative retinopathy
- History of retinal hemorrhage
- uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 120 mm Hg)
- severe baseline electrolyte abnormalities
- medication non-compliance
- uncontrolled metabolic disease (diabetes with fasting blood sugar >300 mg/dl, thyrotoxicosis, myxedema)
- symptomatic peripheral vascular disease
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Intensity Interval Exercise High Intensity Interval Exercise Subjects will receive a recumbent bike to be delivered and assembled to their home as well as a heart rate monitor and activity tracker. Subjects will undergo high intensity interval exercise 3 days a week, with the goal of achieving 85-90% of their heart rate max. Subjects will also be receiving text messages, phone calls, and emails from study staff to gauge and encourage subject participation and physical activity. Moderate Intensity Walking Moderate Intensity Walking Subjects allocated to moderate intensity walking will be given a gift card to purchase a paid of running shoes. A chest-based heart rate monitor and an activity tracker watch will be provided. Subjects will aim to achieve 150 minutes a week of moderate intensity walking. Subjects will also be receiving text messages, phone calls, and emails from study staff to gauge and encourage subject participation and physical activity.
- Primary Outcome Measures
Name Time Method Subject Retention Percentage 22 Weeks This is a feasibility study designed to determine the extent to which eligible patients can be successfully recruited, randomized, and retained. Endpoint data will be used to justify and provide point estimates for a fully powered study. Retention will be measured as a percentage of those enrolled who complete the study interventions.
- Secondary Outcome Measures
Name Time Method Diastolic Function 22 Weeks E' and A' (cm/s) will be used to calculate the E'/A' ratio to assess for diastolic dysfunction and be measured by echocardiogram at pre-chemotherapy and post-chemotherapy
Ejection Fraction 22 Weeks Ejection fraction (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram at pre-chemotherapy and post-chemotherapy
Brachial Artery Endothelium-Dependent Flow-Mediated Dilation 22 Weeks Changes in endothelial function as measured by brachial artery endothelium-dependent flow-mediated dilation (%) at pre-chemotherapy and post-chemotherapy
VO2peak 22 Weeks Change in VO2peak (L/min) measured at pre-chemotherapy and post chemotherapy
Global Longitudinal Strain 22 Weeks Global longitudinal strain (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram at pre-chemotherapy and post-chemotherapy
Carotid-Femoral Pulse Wave Velocity 22 Weeks Changes in arterial stiffness as measured by carotid-femoral pulse wave velocity (m/s) at pre-chemotherapy and post-chemotherapy
Inflammation/Immune cell concentrations in peripheral circulation. 22 Weeks Various markers of inflammation and immune cells will be measured at baseline, pre-chemo (following exercise pre-conditioning), midway through patient's prescribed treatment, and post-intervention to determine changes.
Blood pressure 22 Weeks Brachial systolic and diastolic blood pressures (mmHg) will be measured at baseline and post-chemotherapy.
Lipid panels 22 Weeks A lipid panel will be performed to measure total cholesterol, triglycerides, high-density lipoproteins, and low-density lipoprotein (mg/dl) to assess changes in cardiometabolic health at pre-chemotherapy and post-chemotherapy
Trial Locations
- Locations (1)
University of Virginia University Hospital
🇺🇸Charlottesville, Virginia, United States