Metastatic Breast Cancer
Conditions
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.
Interventions
OTHERWhole-body resistance training and aerobic exercise
A 12-week individualized, home-based, unsupervised, whole-body resistance training and aerobic exercise routine will be provided to each study participant.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score from baseline to Week 13 (end of exercise intervention). | 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 a diagnosis of locally advanced/unresectable or metastatic breast cancer and patients with High-Risk HER 2+ breast cancer after completion of neoadjuvant chemotherapy who are receiving Enhertu therapy. FACIT Fatigue Scored 0 (not at all)- 4(Very Much). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility defined as greater than 75% of all participants completing greater than 66% of all prescribed workouts from baseline to Week 13. | 13 weeks | Test the feasibility of the tested 12-week, home-based, unsupervised aerobic and resistance training exercise program. |
| Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score measured every three weeks from baseline to Week 13. | 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). |
Countries
United States
Contacts
CONTACTJanna Espinosa
CONTACTRoma Bhatia, MD
Outcome results
None listed