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

Utah System of Higher Education (USHE)

Status and phase

Enrolling

Phase 2

Conditions

Metastatic Breast Cancer

Treatments

Other: Whole-body resistance training and aerobic exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07203378

HCI194215

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject aged ≥ 18 years
Diagnosis of locally advanced/unresectable or metastatic breast cancer.
Has received 3 or 4 cycles of Enhertu and is expected to continue treatment for at least 12 weeks.
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.