Recruiting
Phase 2

Aerobic & Resistance Training

Sponsor:

University of Utah

Code:

NCT07203378

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Whole-body resistance training and aerobic exercise

Study Details

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 metastatic breast cancer who are receiving Enhertu.

Conditions

Metastatic Breast Cancer

Study ID

NCT07203378

Start date

Nov 4, 2025

Status verified date

Aug, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise Intervention

no intervention: Usual Care

Interventions

Whole-body resistance training and aerobic exercise

A 12-week individualized, home-based, unsupervised, whole-body resistance training and aerobic exercise routine will be provided to each study participant.

Primary outcome measure

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

Central Contacts and Locations

Locations

Huntsman Cancer Institute at University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

More Information

Sponsor

University of Utah

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-08-20.