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

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

NCT ID: NCT05786014

Condition: Breast Cancer
Cardiotoxicity
Cardiovascular Diseases

Conditions: Official terms:
Breast Neoplasms
Cardiovascular Diseases
Cardiotoxicity

Conditions: Keywords:
chemotherapy
cardiotoxicity
cardiorespiratory fitness

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking description: Subjects and investigators will not be blinded to treatment allocation. Outcome assessors will be blinded.

Intervention:

Intervention type: Behavioral
Intervention name: High Intensity Interval Exercise
Description: 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.
Arm group label: High Intensity Interval Exercise

Intervention type: Behavioral
Intervention name: Moderate Intensity Walking
Description: 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.
Arm group label: Moderate Intensity Walking

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.

Criteria for 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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Virginia University Hospital

Address:
City: Charlottesville
Zip: 22903
Country: United States

Status: Recruiting

Contact:
Last name: Siddhartha S Angadi, PhD

Contact backup:
Last name: Zach Leicht, MS
Email: njn3wg@virginia.edu

Start date: April 1, 2023

Completion date: March 15, 2025

Lead sponsor:
Agency: University of Virginia
Agency class: Other

Source: University of Virginia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05786014