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NCT Number: NCT06938555

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.

Recruiting

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Key information

Conditions

Breast Cancer Survivor Adherence Interventions Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Cancer Related Cognitive Difficulties Fatigue Health Behavior Health Education Medication Adherence Mental Fatigue Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Quality of Life Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Prolonged Nightly Fasting

Behavioral

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

Behavioral

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

  1. 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

  2. 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

Secondary outcomes

  1. Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.

    Time frame: Baseline (T1) and 8-week end point (T2) data collection

    Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep using a scale of 0-21

  2. Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.

    Time frame: Baseline (T1) and 8-week end point (T2) data collection

    Insomnia Severity Index (ISI) will be used to assess insomnia using a scale of 0-28

  3. Examine PNF-induced changes in quality of life as compared to the HED-Only Control condition.

    Time frame: Baseline (T1) and 8-week end point (T2) data collection.

    Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS Global-10) questionnaire will be used to measure health-related quality of life (i.e., mental health, physical health). It uses a scale of 0-20.

Other outcomes

  1. Exploratory Aim: Explore acceptability of the PNF intervention

    Time frame: 8-week end point (T2) data collection

    participant adherence to protocol

  2. Exploratory Aim: Explore acceptability of the PNF intervention

    Time frame: 8-week end point (T2) data collection

    participant retention

  3. Exploratory Aim: Explore acceptability of the PNF intervention

    Time frame: 8-week end point (T2) data collection

    qualitative interviews

  4. Covariate Measure: eating behaviors

    Time frame: Baseline (T1) and 8-week end point (T2) data collection.

    Rapid Eating Assessment for Participants -- Shortened Version (REAPS) will be used to assess food intake quantity and quality changes. This uses a scale of 13-39

Study contacts

Contact information is provided by the study sponsor or research team.

Dorothy Sears, PhD

CONTACT

[email protected]

602-496-3351

Jen Project Coordinator

CONTACT

[email protected]

602-496-8248

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Mayo Clinic

Registry information

Official study title

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

Acronym: RESTORE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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