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

NCT05786014 | Completed DMC

• 1 other identifier: 220287
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Cardiotoxicity; Cardiovascular Diseases

Keywords

chemotherapy; cardiotoxicity; cardiorespiratory fitness

Outcome Measures

Primary Outcomes (1)

• Subject Retention Percentage

  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.

  22 Weeks

Secondary Outcomes (9)

• VO2peak

  22 Weeks

• Global Longitudinal Strain

  22 Weeks

• Ejection Fraction

  22 Weeks

• Diastolic Function

  22 Weeks

• Brachial Artery Endothelium-Dependent Flow-Mediated Dilation

  22 Weeks

Study Arms (2)

Moderate Intensity Walking

EXPERIMENTAL

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.

Behavioral: Moderate Intensity Walking

High Intensity Interval Exercise

EXPERIMENTAL

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.

Behavioral: High Intensity Interval Exercise

Interventions

High Intensity Interval Exercise 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.

High Intensity Interval Exercise

Moderate Intensity Walking 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.

Moderate Intensity Walking

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia University Hospital

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity; Cardiovascular Diseases

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Subjects and investigators will not be blinded to treatment allocation. Outcome assessors will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Education

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 27, 2023
• Study Start: April 1, 2023
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)