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

Recruiting now · Not applicable

Conditions studied: HER2-positive Breast Cancer, Advanced Breast Cancer

In brief

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 education sessions alone) can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a cyclin-dependent kinases-4 and 6 (CDK4/6) inhibitor (e.g., palbociclib, ribociclib, or abemaciclib), with or without HER2-directed therapy (e.g., trastuzumab ± pertuzumab), or in combination with both a CDK4/6 inhibitor and a PI3K inhibitor, within the past 90 days.

Key facts

Study ID: NCT06123988
Run by: University of Miami
People needed: 260
Starts: 2024-09-09
Expected to finish: 2029-09-30
Last updated by the study team: 2025-08-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Miami — Miami, Florida, United States (enrolling)
Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
Arizona State University — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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