Clinical trial NCT05786014: The Effects of Two Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies
Official title: A Feasibility Study to Examine Two Remotely-monitored Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cardiotoxicity
Cardiovascular Diseases
Keywords: chemotherapy
cardiotoxicity
cardiorespiratory fitness
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Subject Retention Percentage
timeFrame: 22 Weeks
Secondary outcomes:
measure: VO2peak
timeFrame: 22 Weeks
measure: Global Longitudinal Strain
timeFrame: 22 Weeks
measure: Ejection Fraction
timeFrame: 22 Weeks
measure: Diastolic Function
timeFrame: 22 Weeks
measure: Brachial Artery Endothelium-Dependent Flow-Mediated Dilation
timeFrame: 22 Weeks
measure: Carotid-Femoral Pulse Wave Velocity
timeFrame: 22 Weeks
measure: Blood pressure
timeFrame: 22 Weeks
measure: Lipid panels
timeFrame: 22 Weeks
measure: Inflammation/Immune cell concentrations in peripheral circulation.
timeFrame: 22 Weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia University Hospital
state: Virginia
Study officials:
References: