12-week home exercise program to boost energy and reduce fatigue for people on Enhertu
ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study
This 12-week home-based aerobic and resistance exercise program will try to reduce cancer-related fatigue in people with metastatic breast cancer who are receiving Enhertu.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | Trastuzumab, Pertuzumab, chemotherapy |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT07203378 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional trial enrolls adults with locally advanced or metastatic breast cancer who are receiving Enhertu and are experiencing clinical fatigue. Participants will follow a 12-week, home-based, unsupervised program combining aerobic activity and whole-body resistance training. Eligible participants will have completed 3 or 4 cycles of Enhertu and be expected to continue treatment for at least 12 weeks, with baseline and follow-up assessments at the study site. The primary outcome is change in cancer-related fatigue over the intervention period.
Who should consider this trial
Good fit: Adults (≥18) with locally advanced/unresectable or metastatic breast cancer who have received 3–4 cycles of Enhertu, are expected to continue it for at least 12 weeks, are experiencing clinical fatigue, and are able and willing to perform home aerobic and resistance exercises.
Not a fit: Patients who cannot safely perform exercise because of comorbid conditions, those not experiencing clinical fatigue, or those unable to attend required study visits are unlikely to receive benefit.
Why it matters
Potential benefit: If successful, the program could decrease fatigue, increase energy, and improve daily functioning for patients receiving Enhertu.
How similar studies have performed: Exercise programs have previously reduced cancer-related fatigue in early-stage and mixed-stage breast cancer populations, but the specific effect during Enhertu treatment is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 6.4.1.
Where this trial is running
Salt Lake City, Utah
- Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Janna Espinosa
- Email: Janna.Espinosa@hci.utah.edu
- Phone: 801-585-0571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.