Effects of fasting and exercise on fatigue in women with advanced breast cancer
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer (FastER)
This study is testing whether fasting, exercise, a mix of both, or health education can help reduce fatigue in postmenopausal women with advanced breast cancer who are starting hormone therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab |
| Locations | 3 sites (Phoenix, Arizona and 2 other locations) |
| Trial ID | NCT06123988 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of four different interventions on fatigue in women with hormone receptor-positive advanced breast cancer. Participants will be assigned to one of four groups: prolonged overnight fasting, moderate-intensity exercise, a combination of both, or general health education sessions. The aim is to determine which approach, if any, can effectively reduce fatigue in patients receiving CDK4/6 inhibitors. The study will include women who are postmenopausal and have recently started endocrine therapy.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women with hormone receptor-positive advanced breast cancer who are starting treatment with a CDK4/6 inhibitor.
Not a fit: Patients who are already engaging in significant physical activity or structured fasting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacological strategies to alleviate fatigue in women undergoing treatment for advanced breast cancer.
How similar studies have performed: While there is ongoing research into lifestyle interventions for cancer-related fatigue, this specific combination of fasting and exercise in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 2 other locations
- Arizona State University — Phoenix, Arizona, United States (Not_yet_recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Tracy E Crane, PhD, RDN — University of Miami
- Study coordinator: Grey Freylersythe, BS
- Email: g.freylersythe@med.miami.edu
- Phone: (305) 243-9832
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.