Status:
RECRUITING
Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu
Lead Sponsor:
University of Utah
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 meta...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07203378
Start Date
November 4 2025
End Date
November 1 2028
Last Update
November 6 2025
Active Locations (1)
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1
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112