Status:
RECRUITING
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
HER2-positive Breast Cancer
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to test if four different programs (prolonged overnighting fasting alone, exercise alone, a combination of prolonged overnight fasting and exercise, or general health educ...
Eligibility Criteria
Inclusion
- Women
- Able to provide written informed consent
- Able to speak, read, and understand English or Spanish
- Postmenopausal (including concurrent use of ovarian suppression)
- Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- or HER-2+ metastatic or locally advanced unresectable breast cancer
- Initiation of first-line or second-line 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) inhibitor, within the past 90 days.
- Prior use of a CDK4/6 inhibitor in the adjuvant setting is permitted; participants must be enrolled within 90 days of starting a CDK4/6 inhibitor for the first or second time in the metastatic or locally advanced setting.
- 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 first or second-line CDK4/6 inhibitor in the metastatic or locally advanced setting.
- 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
- Having not consistently engaged in resistance training 2 or more days per week over the past 3 months
- 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
- Approval from a medical oncology provider to participate.
Exclusion
- Unable to provide consent
- Unable to read or understand English or Spanish
- Oxygen dependent
- Unstable cardiac disease
- Insulin-dependent diabetes
- Unable to walk 2 blocks without assistance (excluding canes)
- Regularly maintaining a shiftwork schedule, i.e. working evening shifts, night shifts, or rotating shifts in the last 3 months
- History of a clinical eating disorder
- Unstable bone metastases
- More than 90 days since initiation of first- or second-line 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 inhibitor, in the metastatic or locally advanced.
- Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06123988
Start Date
September 9 2024
End Date
September 30 2029
Last Update
August 6 2025
Active Locations (3)
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1
Arizona State University
Phoenix, Arizona, United States, 85004
2
University of Miami
Miami, Florida, United States, 33136
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215