Longer overnight fasting and exercise to reduce fatigue in women with hormone receptor–positive advanced breast cancer
Official title: Randomized Phase II Trial of Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FastER)
Funded at University of Miami School of Medicine · NIH-11176126 · Data updated 2026-11-12
This project will see if longer overnight fasting and regular exercise help women with hormone receptor–positive advanced breast cancer feel less fatigued and improve their quality of life.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Miami School of Medicine NIH-funded |
| Lab location | 1 site (Coral Gables, United States) |
| Project start | September 20, 2023 |
| Project end | August 31, 2028 |
| Funding year | 2025 |
| Award (this year) | $2,233,701 |
| NIH project number | 4R01CA281861-03 |
| Project ID | NIH-11176126 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are women with hormone receptor–positive advanced (metastatic) breast cancer who are experiencing fatigue while receiving CDK4/6 inhibitor plus hormonal therapy.
✕Less likely to help
Patients whose fatigue is caused by unrelated medical problems or who cannot safely fast or participate in an exercise program may not experience benefit from these interventions.
What this research studies
If you join, you will be randomly assigned to one of four groups: prolonged overnight fasting, a structured exercise program, both interventions, or usual care. You will report symptoms like fatigue and other quality-of-life measures over the course of the study, and researchers may collect blood samples to look at inflammation and other markers. The trial focuses on women with hormone receptor–positive advanced breast cancer who are taking CDK4/6 inhibitors with hormonal therapy. The goal is to see whether these lifestyle changes can reduce treatment-related fatigue and help people stay on their cancer therapy.
Why it matters
Potential benefit: If successful, these low-cost lifestyle changes could reduce severe fatigue, improve daily functioning, and help women stay on their cancer treatments longer.
How similar studies have gone: Diet and exercise approaches have improved fatigue in early-stage breast cancer, but their benefit for women with advanced HR+ disease on CDK4/6 inhibitors has not been proven.
Where this research is happening
-
University of Miami School of Medicine
Coral Gables, United States Active
Researchers
- Principal investigator: Crane, Tracy E — University of Miami School of Medicine
- Study coordinator: Crane, Tracy E
Related research
Other NIH-funded projects on the same topics.
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Effects of fasting and exercise on fatigue in women with advanced breast cancer
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This project finds how the hormone estrogen can kill certain ER-positive breast cancers and how to tell which patients will benefit.
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Energize-MBC: a web-based fatigue program for women with metastatic breast cancer
This project will adapt a cognitive behavioral therapy program delivered online to help women with metastatic breast cancer who have tiring side effects from CDK4/6 inhibitor treatment.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.