RecruitingPhase 2NCT07203378
Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu
ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study
Sponsor
University of Utah
Enrollment
80 participants
Start Date
Nov 4, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria8
- 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.
Interventions
OTHERWhole-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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07203378
Related Trials
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
NCT06157892139 locations
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
NCT066493311 location
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
NCT059645044 locations
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT0342400545 locations
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
NCT0708576735 locations