Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu
NCT ID: NCT07203378
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-11-04
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise Intervention
Whole-body resistance training and aerobic exercise
A 12-week individualized, home-based, unsupervised, whole-body resistance training and aerobic exercise routine will be provided to each study participant.
Usual Care
No interventions assigned to this group
Interventions
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Whole-body resistance training and aerobic exercise
A 12-week individualized, home-based, unsupervised, whole-body resistance training and aerobic exercise routine will be provided to each study participant.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Locations
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Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Janna Espinosa
Role: primary
Roma Bhatia, MD
Role: backup
Other Identifiers
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HCI194215
Identifier Type: -
Identifier Source: org_study_id