Recruiting
The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors
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.
ClinicalTrials.gov IDNCT06938555
PhaseNA
Enrollment60
SponsorArizona State University
Age18 Years
SexALL
Conditions studied
Breast Cancer Survivor, Cancer Related Cognitive Difficulties, Sleep, Quality of Life
About this study
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 outcomes
- Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition. (Baseline (T1) and 8-week end point (T2) data collection)
- Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition. (Baseline (T1) and 8-week end point (T2) data collection)
Eligibility information
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
Study locations
- Arizona State University, Phoenix, Arizona 85004 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-03.