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

Not Applicable

Not yet recruiting

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT07203378
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-24
• Study Start: 2025-10-01
• Study First Posted: 2025-10-02
• Last Update Submitted: 2025-10-07
• Last Update Posted: 2025-10-09
• Primary Completion: 2027-10
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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.

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.

  • Subject has completed the ACSM exercise preparticipation health screening and is, in the opinion of the investigator, fit to participate in this study..
  • 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Metastatic Breast Cancer recently initiated on Enhertu. FACIT Fatigue Scored 0 (not at all)- 4(Very Much).

Secondary Outcome Measures

Name	Time	Method
Feasibility defined as greater than 75% of all participants completing greater than 66% of all prescribed workouts from baseline to Week 13.	13 weeks	Test the feasibility of the tested 12-week, home-based, unsupervised aerobic and resistance training exercise program.
Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score measured every three weeks from baseline to Week 13.	13 weeks	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).

Trial Locations

Locations (1)

Huntsman Cancer Institute at University of Utah; 🇺🇸 Salt Lake City, Utah, United States