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Exercise for Fatigue in Metastatic Breast Cancer on Enhertu

This study is looking at how a 12-week, home-based exercise program affects fatigue in people with metastatic breast cancer (cancer that has spread to other parts of the body) who are receiving Enhertu. The program involves whole-body resistance training and aerobic exercise. The main goal is to see if this exercise routine can improve your fatigue levels after 13 weeks. You may be able to join if you are at least 18 years old and have locally advanced/unresectable or metastatic breast cancer. The study is currently unclear about its recruitment status and plans to include 80 participants.

Study design
This is an interventional study with a planned enrollment of 80 participants. It is not specified if the study is randomized or blinded.
What's involved
You would participate in a 12-week individualized, home-based, unsupervised, whole-body resistance training and aerobic exercise routine. Your fatigue levels will be measured at the beginning and at Week 13.
Compensation
Not stated in the trial record.
Follow-up
Your fatigue levels will be measured at Week 13, which is the end of the exercise intervention.

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NCT07203378

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Utah
~80 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Whole-body resistance training and aerobic exercise

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score from baseline to Week 13 (end of exercise intervention).
Measured over 13 weeks

Conditions

Metastatic Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Utah1

Who to contact

Janna Espinosa
[email protected]
801-585-0571
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).
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.

What this trial measures

  • Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score from baseline to Week 13 (end of exercise intervention).13 weeks

    Test the preliminary efficacy of a 12-week, home-based, unsupervised aerobic and resistance training exercise program on changes in cancer-related fatigue, in patients with a diagnosis of locally advanced/unresectable or metastatic breast cancer and patients with High-Risk HER 2+ breast cancer after completion of neoadjuvant chemotherapy who are receiving Enhertu therapy. FACIT Fatigue Scored 0 (not at all)- 4(Very Much).