Exercise Program for Breast Cancer Fatigue

(ENERGIZE Trial)

Overseen By Roma Bhatia, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Must be taking: Enhertu

Disqualifiers: Adhering to exercise guidelines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a 12-week home exercise program can reduce fatigue in individuals with metastatic breast cancer undergoing treatment with Enhertu. Participants will either continue their usual care or follow a specific exercise routine, the Nurturing Exercise Routine, which includes aerobic and resistance training. The study seeks individuals already experiencing fatigue and not regularly engaging in structured exercise routines. Those diagnosed with advanced breast cancer and feeling fatigued despite treatment may find this trial suitable. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants taking certain prohibited medications are excluded, so it's best to discuss your current medications with the trial team.

What prior data suggests that this exercise program is safe for patients with metastatic breast cancer?

Research has shown that exercise programs can help reduce tiredness in breast cancer patients. Studies indicate that exercise can boost energy levels and improve overall quality of life. For instance, one study discovered that a 10-week aerobic exercise program greatly reduced tiredness in breast cancer patients.

Exercise routines are generally easy to manage, with most people experiencing no serious side effects. Instead, they often notice improved physical health and increased energy. This makes exercise a promising way to manage tiredness in breast cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nurturing Exercise Routine because it offers a fresh approach to tackling breast cancer-related fatigue, which is often managed with medications and standard physical therapy. Unlike these traditional treatments, this exercise program aims to gently boost energy levels and improve overall well-being through a structured and supportive physical activity plan. The potential for it to enhance quality of life without relying on pharmaceuticals makes it an appealing option for both patients and healthcare providers.

What evidence suggests that this exercise program is effective for reducing breast cancer fatigue?

Research has shown that exercise can help reduce tiredness in breast cancer patients. One study found that exercise led to a noticeable decrease in fatigue. Regular exercise also links to better physical health and an improved quality of life for cancer patients. Another study found that aerobic exercise, such as walking or cycling, was especially effective in reducing tiredness. In this trial, participants in the Exercise Intervention arm will follow a Nurturing Exercise Routine, which could help manage fatigue for those with metastatic breast cancer. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic breast cancer currently being treated with Enhertu. Participants should be able to perform unsupervised exercises at home.

Inclusion Criteria

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

My breast cancer cannot be removed by surgery or has spread.

Exclusion Criteria

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

Currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training ≥ two days per week

Currently participating in structured moderate-intensity aerobic exercise for ≥ 150 minutes per week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week, home-based, unsupervised aerobic and resistance training exercise program

12 weeks

Home-based, unsupervised

Follow-up

Participants are monitored for changes in cancer-related fatigue and physical function after the exercise intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Nurturing Exercise Routine

Trial Overview The study tests a 12-week, home-based exercise program consisting of resistance training and aerobic activities, aiming to reduce cancer-related fatigue in patients.

How Is the Trial Designed?

Group I: Exercise Intervention Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9715478/

Effects of exercise interventions on cancer-related fatigue ... Moderate certainty evidence indicated that exercise could improve fatigue in breast cancer patients (SMD = − 0.40 [95%CI − 0.58, − 0.22]; P = 0.0001).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07203378

Nurturing Exercise Routine for Greater Improvement in Zest ... 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 ...

3. nature.com nature.com/articles/s41598-025-11660-0

Implementing exercise and self-management for women ... Engaging in regular exercise can reduce fatigue, improve cardiovascular fitness, and enhance overall quality of life11,12,13,14,15,16.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960977617304277

The effect of exercise on fatigue and physical functioning in ... There were slightly higher improvements in physical functioning and fatigue when the patients received the intervention after adjuvant breast cancer treatment.

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1491634/full

Which specific modes of exercise training are most ... Additionally, Zou's study revealed that patients with breast cancer who engaged in aerobic exercise exhibited significantly lower Revised Piper Fatigue Scale ( ...

6. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-023-01363-0

Effects of exercise interventions on cancer-related fatigue and ... In this study, exercise interventions were evaluated for their effects on cancer-related fatigue (CRF) and quality of life (QoL) among cancer patients.

7. mdpi.com mdpi.com/2076-3417/14/15/6553

Effects of a Short-Term Supervised Exercise Program in ... In a study by Shobeiri et al. [23], a 10-week aerobic exercise program significantly improved health in breast cancer patients, reducing fatigue ...