Recruiting

Prolonged Nightly Fasting

Sponsor:

Arizona State University

Code:

NCT06938555

Conditions

Breast Cancer Survivor

Cancer Related Cognitive Difficulties

Sleep

Quality of Life

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prolonged Nightly Fasting

Health Education Videos

Study Details

Brief summary:

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.

Conditions

Breast Cancer Survivor

Cancer Related Cognitive Difficulties

Sleep

Quality of Life

Study ID

NCT06938555

Start date

Mar 18, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

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.

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 measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Jen Project Coordinator

602-496-8248restorestudy@asu.edu

Dorothy Sears, PhD

602-496-3351Dorothy.Sears@asu.edu

Locations

Arizona State University

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Jen Project Coordinator

602-496-8248restorestudy@asu.edu

Dorothy Sears, PhD

602-496-3351Dorothy.Sears@asu.edu

Principal Investigator:

Dorothy Sears, PhD

More Information

Sponsor

Arizona State University

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • breast cancer
  • breast cancer survivor
  • brain fog
  • prolonged nightly fasting
  • nationwide
  • remote
  • non-invasive
  • health education
  • sleep
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arizona State University on 2026-05-01.