COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Feasibility Study to Examine Two Remotely-monitored Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies

Quick Facts

Study Start:2023-04-01
Study Completion:2024-08-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05786014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or over
  2. * 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)
  3. * Physician clearance for exercise training
  4. * Speak/understand English
  1. * previous treatment with cardiotoxic chemotherapy
  2. * medical/orthopedic comorbidities that preclude stationary cycling
  3. * significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
  4. * unstable angina or myocardial infarction within 4-weeks prior to treatment
  5. * complex ventricular arrhythmias or New York Heart Association class IV symptoms
  6. * symptomatic severe aortic stenosis
  7. * acute pulmonary embolus
  8. * acute myocarditis
  9. * History of untreated high-risk proliferative retinopathy
  10. * History of retinal hemorrhage
  11. * uncontrolled hypertension (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 120 mm Hg)
  12. * severe baseline electrolyte abnormalities
  13. * medication non-compliance
  14. * uncontrolled metabolic disease (diabetes with fasting blood sugar \>300 mg/dl, thyrotoxicosis, myxedema)
  15. * symptomatic peripheral vascular disease
  16. * Pregnant women

Contacts and Locations

Study Locations (Sites)

University of Virginia University Hospital
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01
Study Completion Date2024-08-26

Study Record Updates

Study Start Date2023-04-01
Study Completion Date2024-08-26

Terms related to this study

Keywords Provided by Researchers

  • chemotherapy
  • cardiotoxicity
  • cardiorespiratory fitness

Additional Relevant MeSH Terms

  • Breast Cancer
  • Cardiotoxicity
  • Cardiovascular Diseases