Prolonged nightly fasting to improve sleep and cognition in breast cancer survivors
Official title: The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)
Run by Arizona State University · NCT06938555 · Data updated 2026-11-12
This study is testing if a nightly fasting plan can help breast cancer survivors improve their sleep, thinking skills, and overall well-being.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Arizona State University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Phoenix, Arizona) |
| Status | Recruiting |
| Started | March 18, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT06938555 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female breast cancer survivors aged 18 and older, who are at least three months post-chemotherapy and experiencing cognitive difficulties.
✕Probably not a fit
Patients with active brain diseases, severe psychological conditions, or those currently on memory-enhancing medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized controlled trial investigates the effects of an 8-week prolonged nightly fasting (PNF) intervention on cognitive function, sleep quality, and overall health-related quality of life in breast cancer survivors experiencing cancer-related cognitive impairment. Participants will be randomly assigned to either the PNF group or a Health Education-Only control group, with both groups receiving health education throughout the study. The trial aims to assess the feasibility of the PNF intervention and its impact on various health outcomes among a diverse population of breast cancer survivors across the United States.
Why it matters
Potential benefit: If successful, this study could enhance cognitive function and sleep quality in breast cancer survivors, improving their overall quality of life.
How similar studies have gone: While the approach of prolonged nightly fasting is innovative, similar studies exploring dietary interventions for cognitive improvement in cancer survivors have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥18 years old 2. diagnosed with breast cancer (all stages included) 3. ≥3 months post neoadjuvant or adjuvant chemotherapy (maintenance or palliative systemic therapy is included) 4. score ≤30 or lower on the Patient Reported Outcome Measurement Information System Cognitive Function Short Form 8a (sr-CRCI) 5. able to speak/understand English 6. have access to a computer and Wi-Fi 7. live within the United States 8. Identifies as female 9. willing and able to fully participate in the study Exclusion Criteria: 1. type 1 diabetes 2. actively enrolled in formal diet/weight loss program 3. previous bariatric surgery 4. eating disorder history 5. night shift work 6. pregnant, breast feeding, or trying to get pregnant 7. dementia, psychological, psychiatric, or neurological diagnoses 8. active brain or central nervous system disease 9. prior or current use of memory enhancing medications 10. history or current brain radiation 11. frequently fasting for 12+ hours every night 13\) history of hypoglycemia 14) depression screening on PHQ9 with a score of 20 or greater across all 9 questions OR anything other than 0 on question 9
Where it's running
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Arizona State University
Phoenix, Arizona, United States Recruiting
Study contacts
- Principal investigator: Dorothy Sears, PhD — Arizona State University
- Study coordinator: Jen Project Coordinator
- Email: restorestudy@asu.edu
- Phone: 602-496-8248
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.