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NCT06123988NARecruiting

Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer

University of Miami

Start Date

9/9/2024

Completion Date

9/30/2029

Summary

The purpose of this study is to test whether four different supportive care programs can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) alongwith endocrine therapy with or without a PI3K or AKT inhibitor.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Women 2. Able to provide written informed consent 3. Able to speak, read, and understand English or Spanish 4. Postmenopausal (including concurrent use of ovarian suppression) 5. Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- or HER-2+ metastatic or locally advanced unresectable breast cancer 6. Initiation of endocrine therapy in combination with a CDK4/6 inhibitor (e.g., palbociclib, ribociclib, or abemaciclib), with or without hormone estrogen receptor-2 (HER2)-directed therapy (e.g., trastuzumab ± pertuzumab), or in combination with both a CDK4/6 inhibitor and a Phosphoinositide 3-kinase (PI3K) or Protein kinase B (AKT) inhibitor, within the past 90 days. a) Participants who switch from one CDK4/6 inhibitor to another due to toxicity or insurance constraints remain eligible, provided enrollment occurs within 90 days of initiating the subsequent CDK4/6 inhibitor in the metastatic or locally advanced setting. 7. Having not consistently (not equal to or more than 50% of the time) engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months 8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months 9. Having not consistently (not equal to or more than 50% of the time) engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months 10. Approval from a medical oncology provider to participate. Exclusion Criteria: 1. Unable to provide consent 2. Unable to read or understand English or Spanish 3. Dependent on supplemental oxygen 4. Unstable cardiac disease 5. Insulin-dependent diabetes 6. Unable to walk 2 blocks without assistance (excluding canes) 7. Regularly maintaining a shiftwork schedule, i.e. working evening shifts, night shifts, or rotating shifts in the last 3 months 8. History of a clinical eating disorder 9. Unstable bone metastases 10. More than 90 days since initiation of endocrine therapy in combination with 1) a CDK4/6 inhibitor, with or without HER2-directed therapy, or 2) a CDK 4/6 inhibitor in combination with a PI3K/AKT inhibitor, in the metastatic or locally advanced. 11. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.

Interventions

BEHAVIORAL

Prolonged Overnight Fasting

BEHAVIORAL

Moderate-Intensity Exercise

BEHAVIORAL

General Health Education Sessions

Interested in This Trial?

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Conditions

HER2-positive Breast CancerAdvanced Breast Cancer

Locations

Arizona State University

Phoenix, Arizona 85004

United States

University of Miami

Miami, Florida 33136

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States