Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole-body resistance training and aerobic exercise.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study
Overview
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.
Interventions
- Other Whole-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.
Primary outcome measures
- Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score from baseline to Week 13 (end of exercise intervention). [Time frame: 13 weeks]
Secondary outcome measures (2)
- Feasibility defined as greater than 75% of all participants completing greater than 66% of all prescribed workouts from baseline to Week 13. [Time frame: 13 weeks]
- Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score measured every three weeks from baseline to Week 13. [Time frame: 13 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Huntsman Cancer Institute at University of Utah — Salt Lake City
Identifiers
NCT: NCT07203378 · HCI194215