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Clinical Trial NCT07203378 (ENERGIZE) for Metastatic Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu (ENERGIZE)

Recruiting
Clinical Trial NCT07203378 (ENERGIZE) is designed to study Treatment for Metastatic Breast Cancer. It is a Phase 2 interventional trial that is recruiting, having started on November 4, 2025, with plans to enroll 80 participants. Led by University of Utah, it is expected to complete by November 1, 2028. The latest data from ClinicalTrials.gov was last updated on November 6, 2025.
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.
Official Title

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study

Conditions
Metastatic Breast Cancer
Other Study IDs
  • ENERGIZE
  • HCI194215
NCT ID Number
NCT07203378
Start Date (Actual)
2025-11-04
Last Update Posted
2025-11-06
Completion Date (Estimated)
2028-11
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExercise Intervention
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.
No InterventionUsual Care
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score from baseline to Week 13 (end of exercise intervention).
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 Metastatic Breast Cancer recently initiated on Enhertu. FACIT Fatigue Scored 0 (not at all)- 4(Very Much).
13 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Feasibility defined as greater than 75% of all participants completing greater than 66% of all prescribed workouts from baseline to Week 13.
Test the feasibility of the tested 12-week, home-based, unsupervised aerobic and resistance training exercise program.
13 weeks
Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score measured every three weeks from baseline to Week 13.
Compare the trajectory of cancer-related fatigue from baseline to Week 13 between patients receiving the exercise intervention versus not. FACIT Fatigue Scored 0 (not at all)- 4 (Very Much).
13 weeks
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Subject aged ≥ 18 years
  • Diagnosis of locally advanced/unresectable or metastatic breast cancer.
  • Has received 3 or 4 cycles of Enhertu and is expected to continue treatment for at least 12 weeks.
  • 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.

-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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Study Central Contact
Contact: Janna Espinosa, 801-585-0571, [email protected]
Contact: Roma Bhatia, MD, 801-585-0255, [email protected]
1 Study Locations in 1 Countries

Utah

Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112, United States
Janna Espinosa, Contact, 801-585-0571, [email protected]
Roma Bhatia, MD, Contact, 801-585-0255, [email protected]
Recruiting