12-week home exercise program to boost energy and reduce fatigue for people on Enhertu

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial enrolls adults with locally advanced or metastatic breast cancer who are receiving Enhertu and are experiencing clinical fatigue. Participants will follow a 12-week, home-based, unsupervised program combining aerobic activity and whole-body resistance training. Eligible participants will have completed 3 or 4 cycles of Enhertu and be expected to continue treatment for at least 12 weeks, with baseline and follow-up assessments at the study site. The primary outcome is change in cancer-related fatigue over the intervention period.

Why it matters

Who can join: the full rules

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 7.4.1.

Where it's running

• Huntsman Cancer Institute at University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Janna Espinosa
• Email: Janna.Espinosa@hci.utah.edu
• Phone: 801-585-0571

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.