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All-extremity Exercise During Breast Cancer Chemotherapy
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 Start (Actual) 5 April 2024
🗓️ Primary Completion (Estimated) 31 May 2026
✅ Study Completion (Estimated) 31 May 2026
👥 Enrollment (Estimated) 68
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Gainesville, Florida, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 28 May 2021
  • First Submitted that Met QC Criteria 3 June 2021
  • First Posted 4 June 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 June 2024
  • Last Update Posted 25 June 2024
  • Last Verified June 2024
I'm interested ...!!