The Effects of Two Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies

NCT ID: NCT05786014

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-08-26

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.

Conditions

Breast Cancer; Cardiotoxicity; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Moderate Intensity Walking

Intervention Type: BEHAVIORAL

Patients will undergo two familiarization training sessions in the exercise physiology core lab to ensure participants understands the walking intervention and can properly gauge intensity. Participants will be asked to walk briskly or jog so they achieve a moderate intensity (70-75% of the maximal heart rate achieved during the VO2peak test). The goal for participants in this condition will be to accumulate at least 150-minutes per week at this heart rate by brisk walking or jogging. Participants will also receive a gift card to be used to purchase a pair of walking shoes to facilitate their engagement.

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.

Group Type: EXPERIMENTAL

High Intensity Interval Exercise

Intervention Type: BEHAVIORAL

Patients in the Cycling Intervention arm will undergo two training sessions at the exercise physiology core lab to ensure participants understand the intervention exercise protocol and can safely perform it at home. The Participants will perform high intensity interval training (HIIT) 3 days per week, with each session consisting of four, 4-min intervals at 85-90% peak heart rate (PHR), separated by 3 min at 50% PHR. Each training session will begin with a 10-minute warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR. Subjects will then perform this exercise training at their own homes using recumbent exercise bikes provided by the investigators for that purpose. Study investigators will check in up to weekly with participants and remotely track exercise data and compliance via activity tracker.

Interventions

High Intensity Interval Exercise

Patients in the Cycling Intervention arm will undergo two training sessions at the exercise physiology core lab to ensure participants understand the intervention exercise protocol and can safely perform it at home. The Participants will perform high intensity interval training (HIIT) 3 days per week, with each session consisting of four, 4-min intervals at 85-90% peak heart rate (PHR), separated by 3 min at 50% PHR. Each training session will begin with a 10-minute warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR. Subjects will then perform this exercise training at their own homes using recumbent exercise bikes provided by the investigators for that purpose. Study investigators will check in up to weekly with participants and remotely track exercise data and compliance via activity tracker.

Intervention Type: BEHAVIORAL

Moderate Intensity Walking

Patients will undergo two familiarization training sessions in the exercise physiology core lab to ensure participants understands the walking intervention and can properly gauge intensity. Participants will be asked to walk briskly or jog so they achieve a moderate intensity (70-75% of the maximal heart rate achieved during the VO2peak test). The goal for participants in this condition will be to accumulate at least 150-minutes per week at this heart rate by brisk walking or jogging. Participants will also receive a gift card to be used to purchase a pair of walking shoes to facilitate their engagement.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Siddartha Angadi

Assistant Professor of Education

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Virginia University Hospital

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

220287

Identifier Type: -

Identifier Source: org_study_id