This clinical trial evaluates whether home-based cycling and walking interventions started prior to standard cancer treatments and continued throughout treatment, reduces the side effects of traditional chemotherapy in patients with breast cancer undergoing cardiotoxic (any heart damage arising from cancer treatment) chemotherapies. Breast cancer is the most common form of cancer affecting women in the United States (US) and survivors experience long-term health effects of chemotherapy. While standard treatment for cancer is effective at dealing with cancer status, it has side effects such as reduced quality of life, and increased risk of cardiovascular disease, including heart failure and stroke. Exercise training is a promising treatment to reduce 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 chemotherapy on cardiotoxic outcomes are unknown. This study may help researchers learn how remotely-monitored exercise interventions may improve preservation of cardiac/skeletal muscle health, cognitive function, and quality of life in patients with breast cancer undergoing cardiotoxic chemotherapies. In the future, remotely-monitored exercise interventions may potentially lead to a larger randomized controlled study to assess how a prescribed, home-based exercise regimens affect the off-target effects associated with cancer chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05786014.
PRIMARY OBJECTIVE:
I. This is a feasibility study designed to determine the extent to which eligible patients can be successfully recruited, randomized, and retained.
SECONDARY OBJECTIVES:
I. Assess the effect that treatment has on measures of cardiorespiratory fitness and cardiac function.
II. Examine treatment engagement with and the acceptability of the remotely monitored exercise interventions.
III. Explore the relationship between engagement in the exercise training and psychosocial function.
IV. Examine effects of treatment on measures of vascular function.
V. Assess the effect that treatment has on immune cell populations and immune cell senescence.
OUTLINE:
EXERCISE INTERVENTION: Patients are randomized to 1 of 2 arms.
ARM A: Patients attend two in-person training sessions and participate in at-home high-intensity interval training (HIIT) over 40 minutes 3 days per week (TIW) on a stationary bike for 4 months (or duration of chemotherapy regimen) on study. Patients also wear activity tracker and heart rate monitor to monitor activity throughout study, receive stationary bike, receive one core laboratory (lab) phone call, and emails or text messages up to 4 times per week on study. Patients undergo echocardiography (ECHO) and blood sample collection on study.
ARM B: Patients attend two in-person training sessions and participate in at-home moderate intensity exercise (brisk walking/jogging) over 150 minutes per week for 4 months (or duration of chemotherapy regimen) on study. Patients also wear activity tracker and heart rate monitor to monitor activity throughout study, receive a pair of walking shoes, receive one core lab phone call, and emails or text messages up to 4 times per week. Patients also undergo ECHO and blood sampled collection on study.
NO-EXERCISE INTERVENTION: Patients assigned to Arm III and healthy controls to Arm IV.
ARM C: Patients receive standard of care (SOC) treatment and undergo ECHO and blood sample collection, as well as wear activity tracker and heart rate monitor to monitor activity on study.
ARM D: Healthy age-matched controls undergo ECHO and blood sample collection, as well as wear activity tracker and heart rate monitor to monitor activity on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorSiddhartha S. Angadi
