Actively Recruiting
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
Led by University of Miami · Updated on 2025-08-06
260
Participants Needed
3
Research Sites
263 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women
- Able to provide written informed consent
- Able to speak, read, and understand English or Spanish
- Postmenopausal (including use of ovarian suppression)
- Diagnosis of ER+ and/or PR+, HER2- or HER2+ metastatic or locally advanced unresectable breast cancer
- Started first- or second-line endocrine therapy with a CDK4/6 inhibitor, with or without HER2-directed therapy, or combined with a PI3K inhibitor within the past 90 days
- Prior CDK4/6 inhibitor use in adjuvant setting allowed; must enroll within 90 days of starting CDK4/6 inhibitor for metastatic or locally advanced cancer
- Switching between CDK4/6 inhibitors due to toxicity or insurance allowed if within 90 days of starting in metastatic or locally advanced setting
- Not consistently engaged in over 90 minutes of moderate or 45 minutes of vigorous physical activity per week in past 3 months
- Not consistently engaged in resistance training 2 or more days per week in past 3 months
- Not consistently fasted overnight for 12 hours or more in past 3 months
- Medical oncology provider approval to participate
You will not qualify if you...
- 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)
- Working evening, night, or rotating shifts regularly in last 3 months
- History of a clinical eating disorder
- Unstable bone metastases
- More than 90 days since starting first- or second-line endocrine therapy with CDK4/6 inhibitor, with or without HER2-directed therapy or combined with PI3K inhibitor
- Severe medical or psychiatric condition or medications preventing study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Arizona State University
Phoenix, Arizona, United States, 85004
Not Yet Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
G
Grey Freylersythe, BS
CONTACT
T
Tracy E Crane, PhD, RDN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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