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Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu
RECRUITINGPhase 2Sponsored by University of Utah
Actively Recruiting
PhasePhase 2
SponsorUniversity of Utah
Started2025-11-04
Est. completion2027-11
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07203378
Summary
The goal of this study is to test the efficacy of using a 12-week, home-based, unsupervised aerobic and resistance training exercise program for changes in cancer-related fatigue in patients with metastatic breast cancer who are receiving Enhertu.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * Subject aged ≥ 18 years * Diagnosis of locally advanced/unresectable or metastatic breast cancer. * Has received 3 or 4 cycles of Enhertu and is expected to continue treatment for at least 12 weeks. * Able and willing to participate in the interventional aerobic exercise and resistance exercises. * Currently following standard of care contraception requirements and willing to continue following these requirements for the duration of therapy. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. * Experiencing clinical fatigue symptoms in the opinion of the investigator. * Subject has completed the ACSM exercise preparticipation health screening and is, in the opinion of the investigator, fit to participate in this study. Exclusion Criteria: -Currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training ≥ two days per week. * Structured is defined as time set aside in the subject's day to workout. * Resistance training is defined as exercises which use weights, bands, or body weight (e.g., squats or push-ups). AND Currently participating in structured moderate-intensity aerobic exercise for ≥ 150 minutes per week. * Moderate-intensity exercise is defined as activities where the subject can talk but not sing. * Aerobic exercise includes, but is not limited to, walking, swimming, cycling, running, rowing, hiking, and elliptical. * Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study. * Participants taking prohibited medications as described in Section 6.4.1.
Conditions3
Breast CancerCancerMetastatic Breast Cancer
Locations1 site
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
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Actively Recruiting
PhasePhase 2
SponsorUniversity of Utah
Started2025-11-04
Est. completion2027-11
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07203378