NCT06938555 · Arizona State University
The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors
(RESTORE)
What this study is about
The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.
View original scientific description
The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.
Interventions
BEHAVIORAL
Prolonged Nightly Fasting
At the start of the intervention (week 1) PNF participants will be asked to engage in fasting (14 hours a night, starting no later than 8pm) six nights a week (for the 8-week study duration). Participants will be asked to track their fasting start/stop times on a tracking sheet provided by study staff. During the nightly fast, participants will be allowed to drink water, coffee or tea (without dairy or sweeteners). Study staff will meet with participants via phone for weekly check-in calls (\~10-15 mins) to collect weekly fasting start/stop dates/times (entered into REDCap); alternately, participants may elect to email or text their fasting start/stop date/times to the study staff.
BEHAVIORAL
Health Education Videos
Provision of HED is a retention strategy and can influence outcomes. Thus, all participants will receive HED. Each week, participants will receive hyperlinks to videos focused on health educational content unrelated to fasting, diet and outcome measures. Participants will be asked to view the videos (\~10-15 min) prior to their weekly check-in calls with the study staff (\~5-10 mins for HED-Only Control group). They will receive each week's videos on a Monday, and receive a reminder to view on Friday. Study staff will follow a scripted HED weekly check-in call to ensure consistency of data collected. Weekly topics are as follows: W1: Internet safety, W2: Sun safety, W3: Home safety, W4: Driving safety, W5: Hydration, W6: Dental health, W7: Working environment, W8: Communication. Data collected on electronic forms during all participant/staff check-in calls will be stored in participant-specific ASU Dropbox files.
Primary outcome measures
Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition.
Time frame: Baseline (T1) and 8-week end point (T2) data collection
The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess subjective cognitive function using a scale of 0-156
Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition.
Time frame: Baseline (T1) and 8-week end point (T2) data collection
The Montreal Cognitive Assessment (T-MoCA) will be used to assess objective cognitive assessment using a scale of 0-22
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥18 years old
- diagnosed with breast cancer (all stages included)
- ≥3 months post neoadjuvant or adjuvant chemotherapy (maintenance or palliative systemic therapy is included)
- score ≤30 or lower on the Patient Reported Outcome Measurement Information System Cognitive Function Short Form 8a (sr-CRCI)
- able to speak/understand English
- have access to a computer and Wi-Fi
- live within the United States
- Identifies as female
- willing and able to fully participate in the study
Exclusion criteria
- type 1 diabetes
- actively enrolled in formal diet/weight loss program
- previous bariatric surgery
- eating disorder history
- night shift work
- pregnant, breast feeding, or trying to get pregnant
- dementia, psychological, psychiatric, or neurological diagnoses
- active brain or central nervous system disease
- prior or current use of memory enhancing medications
- history or current brain radiation
- 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
- Phoenix, Arizona
Collaborators
Mayo Clinic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations