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

NCT07203378 | Recruiting Phase 2 DMC

• 1 other identifier: HCI194215
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  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).

  13 weeks

Secondary Outcomes (2)

• Feasibility defined as greater than 75% of all participants completing greater than 66% of all prescribed workouts from baseline to Week 13.

  13 weeks

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

  13 weeks

Other Outcomes (22)

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

  13 weeks

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

  13 weeks

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

  12 weeks

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

Other: Whole-body resistance training and aerobic exercise

Usual Care

NO INTERVENTION

Interventions

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.

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Janna Espinosa

CONTACT

801-585-0571; Janna.Espinosa@hci.utah.edu

Roma Bhatia, MD

CONTACT

801-585-0255; Roma.bhatia@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 2, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)