Clinical Trial 23521

• Overview

  Study Title:

  High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer Chemotherapy

  Summary:

  Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.

  Objective:

  Primary Objective: To investigate (1) the short-term and prolonged effects of HIIT-ANE, MICT-ANE and UC on endothelial function (flow-mediated dilation; FMD) assessed by high-resolution ultrasonography in women who have recently completed chemotherapy for primary non-metastatic breast cancer; and (2) the durability of the endothelial effects of HIIT-ANE vs. MICT-ANE. Secondary Objectives: To investigate (1) the short-term and prolonged effects of HIIT-ANE, MICT-ANE and UC on cardiac function (global longitudinal strain; GLS) assessed by speckle tracking echocardiography in women who have recently completed chemotherapy for primary non-metastatic breast cancer; and (2) the durability of the cardiac effects of HIIT-ANE vs. MICT-ANE. In addition, we will examine the feasibility, tolerability, and safety of HIIT-ANE and MICT-ANE in this patient population. Other secondary measures will include relevant cardiovascular measures (conventional echocardiography measures, blood pressure, arterial structure and function, arterial stiffness, heart rate variability), cognitive function, physical function, fatigue, quality of life, disease- and treatment-related measures, VO2peak, body composition, physical activity, and diet.

• Inclusion Criteria

  Inclusion Criteria:
  • Female patients based on biological sex.
  • 18 to 85 years of age.
  • Diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer.
  • Completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy, and bisphosphonates are allowed within 6 months of study enrollment and during study participation.
  • Absence of contraindications to exercise or to participate in study.
  • Study clinician approval.

• Exclusion Criteria

  Exclusion Criteria:
  • Do not meet inclusion criteria.
  • Scheduled to receive surgery or radiation therapy during the intervention period.
  • 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).
  • Lymphedema stage ≥2 prior to study enrollment.
  • Are pregnant.
  • Current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss).

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