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Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
NCT06123988 · University of Miami
In plain English
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Official title
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer (FastER)
About this study
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.
Eligibility criteria
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 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.
1. 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.
2. 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.
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. Oxygen dependent
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 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.
11. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.
Study design
Enrollment target: 260 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-09-09
Estimated completion: 2029-09-30
Last updated: 2025-08-06
Interventions
Behavioral: Prolonged Overnight FastingBehavioral: Moderate-Intensity ExerciseBehavioral: General Health Education Sessions
Primary outcomes
- • Change in Cancer-Related Fatigue as Measured by EORTC QLQ-C30 Scores (Baseline, 12 weeks)
Sponsor
University of Miami · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactGrey Freylersythe, BS · contact · g.freylersythe@med.miami.edu · (305) 243-9832
ContactTracy E Crane, PhD, RDN · contact · tecrane@med.miami.edu · (305) 243-8255
InvestigatorTracy E Crane, PhD, RDN · principal_investigator, University of Miami
InvestigatorCarmen Calfa, MD · principal_investigator, University of Miami
All locations (3)
Arizona State UniversityNot Yet Recruiting
Phoenix, Arizona, United States
University of MiamiRecruiting
Miami, Florida, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States