The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06938555
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Arizona State University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dorothy Sears, PhDSarah James, MD, PhD
Principal Investigator Affiliation	Arizona State UniversityMayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer Survivor, Cancer Related Cognitive Difficulties, Sleep, Quality of Life

Additional Details

The purpose of this innovative, remotely-delivered pilot randomized controlled trial (RCT) is to explore the use of an 8-week prolonged nightly fasting (PNF) intervention, as compared to a Health Education-Only (HED-Only) control condition, among ethnically and racially diverse (≥50% Black, Hispanic, and/or Native American) breast cancer survivors (BCSs) with cancer-related cognitive impairment (CRCI) to examine changes in cognitive function, sleep, insomnia and health-related quality of life (i.e., mental and physical). Additionally, intervention feasibility will be assessed among the PNF participants. All participants will receive health education (HED) throughout. BCSs living with CRCI (N=60) will be recruited nationwide and randomized 1:1 into the PNF or HED-Only groups. Linear mixed models will be used to compare outcome changes in the PNF group compared to HED-Only group (Aims 1-3); descriptive and qualitative analyses will be used in the Exploratory Aim.

Arms & Interventions

Arms

Experimental: Prolonged Nightly Fasting and Health Education Videos

Participants in the Prolonge + HED condition will receive both the Prolonged Nightly Fasting and the Health Education Video interventions.

Active Comparator: Health Education Videos Only

Participants in the Health Education Only condition will participate in only the Health Education Video intervention. Investigators will provide materials about Prolonged Nightly Fasting to these participants at the end of the study.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arizona State University, Phoenix, Arizona

Status

Recruiting

Address

Arizona State University

Phoenix, Arizona, 85004

Site Contact

Jen Project Coordinator

[email protected]

602-496-8248

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