Prolonged nightly fasting to improve sleep and cognition in breast cancer survivors
The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Arizona State University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT06938555 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with active brain diseases, severe psychological conditions, or those currently on memory-enhancing medications may not benefit from this study.
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 performed: While the approach of prolonged nightly fasting is innovative, similar studies exploring dietary interventions for cognitive improvement in cancer survivors have shown promising results.
Eligibility criteria
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 this trial is running
Phoenix, Arizona
- 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
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.