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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a 12-week home exercise program can reduce cancer-related tiredness in people receiving Enhertu for breast cancer. The program includes aerobic exercise, which gets your heart beating faster, and strength exercises, done without supervision. It is mainly for people whose breast cancer has spread or cannot be removed with surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have breast cancer that has spread nearby and cannot be removed with surgery, or has spread to other parts of the body. Your doctor may also allow you to join if you have high-risk HER2-positive breast cancer, finished chemotherapy before surgery, and need Enhertu after surgery.
  • You have received 3 or 4 rounds of Enhertu and are expected to continue for at least 12 weeks. Other HER2-targeted treatments may be used with Enhertu.
  • You are able and willing to do aerobic and strength exercises.
  • You follow the required birth control rules and agree to keep following them during treatment.
  • You can understand and agree to join the study and are willing to sign a consent form.
  • The study doctor believes you have symptoms of cancer-related tiredness.
  • You have completed the ACSM health screening for exercise, and the study doctor believes you can safely take part.

Who can't join

  • You already set aside time for BOTH strength training at least 2 days a week AND moderate aerobic exercise at least 150 minutes a week. Strength training uses weights, bands, or body weight. Moderate aerobic exercise, such as brisk walking, lets you talk but not sing.
  • You have a medical, mental health, thinking, or other condition that could keep you from understanding the study, agreeing to join, following its rules, or finishing it.
  • You take medicines that the study does not allow, as listed in Section 7.4.1 of the study plan.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 7.4.1.

Study sites (1)

UT