Recruiting

Exercise

Sponsor:

University of Florida

Code:

NCT04914663

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise training

Study Details

Brief summary:

Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.

Conditions

Breast Cancer

Study ID

NCT04914663

Start date

Apr 5, 2024

Status verified date

Aug, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III
  • Female
  • 18 to 85 years of age
  • Scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane)
  • Absence of contraindications to exercise
  • Study clinician approval
  • Able to give consent
  • Informed consent obtained from the subject and documentation of subject agreement to comply with study-related process

Exclusion Criteria:

  • Do not meet inclusion criteria
  • Receiving targeted therapies (CDK4/6 or PARP inhibitors)
  • Receiving radiation therapy concurrent with chemotherapy
  • Lymphedema stage ≥ 2 prior to study enrollment
  • Any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
  • Current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: All-extremity exercise

active comparator: Treadmill exercise

no intervention: Usual Care

Interventions

Exercise training

Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.

Primary outcome measure

  • Change in brachial artery FMD [ Time Frame: 12 weeks ]
  • Change in global longitudinal strain [ Time Frame: 12 weeks ]
  • Feasibility, tolerability and safety of exercise training during breast cancer chemotherapy [ Time Frame: Monitored throughout the 12 weeks of intervention ]

Central Contacts and Locations

Central contacts

Demetra Christou, PhD

3522941746ddchristou@ufl.edu

Eileen Handberg

352-273-9082handbem@medicine.ufl.edu

Locations

Integrative Cardiovasculal Physiology Laboratory, University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Demetra Christou, PhD

352-294-1746ddchristou@ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Oct 1, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-10-01.