Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu
Recruiting
Phase 2Interventional Study
Metastatic Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
University of Utah · Other
Who this trial is looking for
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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.
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Eligibility Criteria
Inclusion Criteria:
* Subject aged ≥ 18 years
* Diagnosis of locally advanced/unresectable or metastatic breast cancer. Note: Patients with High-Risk HER-2 + breast cancer after completion of neoadjuvant chemotherapy requiring adjuvant Enhertu are allowed at the discretion of the treating physician…
Inclusion Criteria:
* Subject aged ≥ 18 years
* Diagnosis of locally advanced/unresectable or metastatic breast cancer. Note: Patients with High-Risk HER-2 + breast cancer after completion of neoadjuvant chemotherapy requiring adjuvant Enhertu are allowed at the discretion of the treating physician.
* Has received 3 or 4 cycles of Enhertu and is expected to continue treatment for at least 12 weeks. Note: HER-2 targeted systemic therapy (e.g. Trastuzumab and/or Pertuzumab) in conjunction with Enhertu is allowed.
* 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.
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