Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu
Recruiting · NCT07203378 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Utah
View the official record on ClinicalTrials.gov →Interventions studied
Whole-body resistance training and aerobic exercise
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 7.4.1.
Where it is running
1 location listed across 1 US state.
- Huntsman Cancer Institute at University of Utah - Salt Lake City, Utah, United States