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Recruiting Phase 2

Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu

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About this study

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.

Condition
Metastatic Breast Cancer
Tested
Whole-body resistance training and aerobic exercise
Sponsor
University of Utah

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Study condition: Metastatic Breast Cancer
  • 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 8

  • 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 7.4.1.

Where

1 site, 1 recruiting

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.