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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Utah
Huntsman Cancer Institute at University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Janna Espinosa
Janna.Espinosa@hci.utah.edu
801-585-0571
Backup
Roma Bhatia, MD
Roma.bhatia@hci.utah.edu
801-585-0255
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2028-11
Participants
Target number of participants: 80
Treatments
Experimental: Exercise Intervention
No_intervention: Usual Care
Related Therapeutic Areas
Sponsors
Leads: University of Utah

This content was sourced from clinicaltrials.gov