Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07203378

Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole-body resistance training and aerobic exercise

Other

A 12-week individualized, home-based, unsupervised, whole-body resistance training and aerobic exercise routine will be provided to each study participant.

Primary outcomes

  1. Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score from baseline to Week 13 (end of exercise intervention).

    Time frame: 13 weeks

    Test the preliminary efficacy of a 12-week, home-based, unsupervised aerobic and resistance training exercise program on changes in cancer-related fatigue, in patients with Metastatic Breast Cancer recently initiated on Enhertu. FACIT Fatigue Scored 0 (not at all)- 4(Very Much).

Secondary outcomes

  1. 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

    Test the feasibility of the tested 12-week, home-based, unsupervised aerobic and resistance training exercise program.

  2. Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score measured every three weeks from baseline to Week 13.

    Time frame: 13 weeks

    Compare the trajectory of cancer-related fatigue from baseline to Week 13 between patients receiving the exercise intervention versus not. FACIT Fatigue Scored 0 (not at all)- 4 (Very Much).

Other outcomes

  1. Change in Functional Assessment of Cancer Therapy - Breast (FACT-B) score from baseline to Week 13.

    Time frame: 13 weeks

    Evaluate the preliminary efficacy of the exercise intervention on breast cancer-related quality of life. FACT-B scored 0 (not at all)- 4 (Very Much).

  2. Mean Functional Assessment of Cancer Therapy - Breast (FACT-B) score measured every three weeks from baseline to 13 weeks after initiation of training.

    Time frame: 13 weeks

    Compare the trajectory of breast cancer-related quality of life from baseline to Week 13 after initiation of training between patients receiving the exercise intervention versus not. FACT-B scored 0 (not at all)- 4 (Very Much).

  3. Change in the average time spent in moderate to vigorous physical activity (in minutes)

    Time frame: 12 weeks

    Evaluate the preliminary efficacy of the exercise intervention on exercise engagement. At one week prior to baseline (i.e. baseline), at the midpoint of the intervention (Week 6) and during the final week of the intervention (Week 12), as measured by the Actigraph GT9x Link accelerometer.

  4. Markers evaluating activity collected from the Actigraph, such as time spent in light activity.

    Time frame: 12 weeks

    Evaluate the preliminary efficacy of the exercise intervention on exercise engagement.

  5. Markers evaluating activity collected from the Actigraph, such as step count.

    Time frame: 12 weeks

    Evaluate the preliminary efficacy of the exercise intervention on exercise engagement.

  6. Average time spent in moderate to vigorous physical activity (in minutes) measured at baseline, Week 6, and Week 12 by the Actigraph GT9x Link accelerometer.

    Time frame: 12 weeks

    Compare the trajectory of exercise engagement from baseline to 12 weeks between patients receiving the exercise intervention versus not.

  7. Other markers evaluating activity collected daily from the Actigraph GT9x, such as step count.

    Time frame: 12 weeks

    Compare the trajectory of exercise engagement from baseline to 12 weeks between patients receiving the exercise intervention versus not.

  8. Other markers evaluating activity collected daily from the Actigraph GT9x, such as time spent in light activity.

    Time frame: 12 weeks

    Compare the trajectory of exercise engagement from baseline to 12 weeks between patients receiving the exercise intervention versus not.

  9. Change in mean PROMIS Physical Function score from baseline to Week 13.

    Time frame: 13 weeks

    Evaluate the preliminary efficacy of the exercise intervention on physical function. Scored 5 (Without any difficulty)- 1 (Unable to do).

  10. Change in the following objective measures of physical function from baseline to Week 13: 30-second chair stand.

    Time frame: 13 weeks

    Evaluate the preliminary efficacy of the exercise intervention on physical function.

  11. Change in the following objective measures of physical function from baseline to Week 13: Balance Test

    Time frame: 13 weeks

    Evaluate the preliminary efficacy of the exercise intervention on physical function. The Balance Test will consist of: Participants will be instructed to stand up with their feet in three different positions (side-by-side, tandem and semi-tandem) for 10 seconds each position.

  12. Change in the following objective measures of physical function from baseline to Week 13: 30-second maximum push-up test.

    Time frame: 13 weeks

    Evaluate the preliminary efficacy of the exercise intervention on physical function.

  13. Average physical function measured at baseline, Week 6, and Week 12 by PROMIS Physical Function score.

    Time frame: 12 weeks

    Compare the trajectory of physical function from baseline to 12 weeks between patients receiving the exercise intervention versus not. Scored 5 (Without any difficulty)- 1 (Unable to do).

  14. Other markers evaluating physical function, including 30-second chair stand.

    Time frame: 12 weeks.

    Compare the trajectory of physical function from baseline to 12 weeks between patients receiving the exercise intervention versus not.

  15. Other markers evaluating physical function, including a Balance Test.

    Time frame: 12 weeks.

    Compare the trajectory of physical function from baseline to 12 weeks between patients receiving the exercise intervention versus not.

    The Balance Test will consist of: Participants will be instructed to stand up with their feet in three different positions (side-by-side, tandem and semi-tandem) for 10 seconds each position.

  16. Other markers evaluating physical function, including a 30-second maximum push-up test.

    Time frame: 12 weeks.

    Compare the trajectory of physical function from baseline to 12 weeks between patients receiving the exercise intervention versus not.

  17. Change in Sit-to-Stand score patterns as measured by actigraphy (central measure of fatigue) from baseline to Week 13.

    Time frame: 13 weeks

    Evaluate the preliminary efficacy of the exercise intervention on measures of peripheral and central fatigue.

  18. Change in handgrip strength (peripheral measures of fatigue) patterns as measured by actigraphy (central measure of fatigue) from baseline to Week 13.

    Time frame: 13 weeks

    Evaluate the preliminary efficacy of the exercise intervention on measures of peripheral and central fatigue.

  19. Change in the number of rest-activity patterns as measured by actigraphy (central measure of fatigue) from baseline to Week 13.

    Time frame: 13 weeks

    Evaluate the preliminary efficacy of the exercise intervention on measures of peripheral and central fatigue.

  20. Mean score for sit-to-stand patterns measured at baseline, 6-weeks, and Week 13.

    Time frame: 13 weeks

    Compare the trajectory of measures of peripheral and central fatigue baseline to Week 13 after initiation of training between patients receiving the exercise intervention versus not.

  21. Mean score for handgrip strength patterns measured at baseline, 6-weeks, and Week 13.

    Time frame: 13 weeks

    Compare the trajectory of measures of peripheral and central fatigue baseline to Week 13 after initiation of training between patients receiving the exercise intervention versus not.

  22. Mean number of rest-activity patterns measured at baseline, 6-weeks, and Week 13.

    Time frame: 13 weeks

    Compare the trajectory of measures of peripheral and central fatigue baseline to Week 13 after initiation of training between patients receiving the exercise intervention versus not.

Study contacts

Contact information is provided by the study sponsor or research team.

Janna Espinosa

CONTACT

[email protected]

801-585-0571

Roma Bhatia, MD

CONTACT

[email protected]

801-585-0255

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study

Acronym: ENERGIZE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 2, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.