Breast Cancer SurvivorRESTORENCT06938555
The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors
A study testing Prolonged Nightly Fasting and Health Education Videos in people with Breast Cancer Survivor and Cancer Related Cognitive Difficulties, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Survivor, Cancer Related Cognitive Difficulties, Sleep
- What is being tested?
- Prolonged Nightly Fasting and Health Education Videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Show all 9Show fewer
- live within the United States
- Identifies as female
- willing and able to fully participate in the study
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arizona State University
Phoenix, Arizona, 85004
Jen Project Coordinator, 602-496-8248, restorestudy@asu.edu
Dorothy Sears, PhD, 602-496-3351, Dorothy.Sears@asu.edu
About this study
Official title: The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)
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.
Read the detailed description
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.
- Being tested
- Prolonged Nightly Fasting, Health Education Videos
- Keywords
- breast cancer, breast cancer survivor, brain fog, prolonged nightly fasting, nationwide, remote, non-invasive, health education, sleep, quality of life
- Medical subject headings
- Breast Neoplasms, Mental Fatigue, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Nightly FastingBehavioural
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 VideosBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Nightly Fasting and Health Education Videos | Experimental | Participants in the Prolonge + HED condition will receive both the Prolonged Nightly Fasting and the Health Education Video interventions. Receives: Behavioral: Prolonged Nightly Fasting; Behavioral: Health Education Videos |
| Health Education Videos Only | Active comparator | 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. Receives: Behavioral: Health Education Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition.
The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess subjective cognitive function using a scale of 0-156
Measured: 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.
The Montreal Cognitive Assessment (T-MoCA) will be used to assess objective cognitive assessment using a scale of 0-22
Measured: Baseline (T1) and 8-week end point (T2) data collection
Secondary outcomes (3)
Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.
Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep using a scale of 0-21
Measured: Baseline (T1) and 8-week end point (T2) data collection
Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.
Insomnia Severity Index (ISI) will be used to assess insomnia using a scale of 0-28
Measured: Baseline (T1) and 8-week end point (T2) data collection
Examine PNF-induced changes in quality of life as compared to the HED-Only Control condition.
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.
Measured: Baseline (T1) and 8-week end point (T2) data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start18 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will be assigned to Prolonged Nightly Fasting (PNF) and Health Education videos, the other group will be assigned to Health Education videos.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Dorothy Sears, Arizona State University
- Investigators
- Dorothy Sears, PhD, Principal investigator, Arizona State UniversitySarah James, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938555
- Sponsor's protocol ID
- STUDY00021379
- Acronym
- RESTORE
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protocol and consent state, "De-identified data collected as a part of this study will not be shared with other investigators or industry partners for future research purposes." This is a pilot study and only aggregated data may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)
- ClinicalTrials.gov ID
- NCT06938555
- Acronym / sponsor ID
- RESTORE / STUDY00021379
- Keywords
- breast cancer, breast cancer survivor, brain fog, prolonged nightly fasting, nationwide, remote, non-invasive, health education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- One group will be assigned to Prolonged Nightly Fasting (PNF) and Health Education videos, the other group will be assigned to Health Education videos.
| Arm | Type | Receives |
|---|---|---|
| Prolonged Nightly Fasting and Health Education Videos | Experimental | Behavioral: Prolonged Nightly Fasting, Behavioral: Health Education VideosParticipants in the Prolonge + HED condition will receive both the Prolonged Nightly Fasting and the Health Education Video interventions. |
| Health Education Videos Only | Active comparator | Behavioral: Health Education VideosParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥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
Key exclusion criteria (12 listed)
- type 1 diabetes
- actively enrolled in formal diet/weight loss program
- previous bariatric surgery
- eating disorder history
- night shift work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Nightly FastingAt 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. | Behavioural | Prolonged Nightly Fasting and Health Education Videos |
| Health Education VideosProvision 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. | Behavioural | Health Education Videos Only, Prolonged Nightly Fasting and Health Education Videos |
Primary outcome
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
3 secondary outcomes
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. Protocol and consent state, "De-identified data collected as a part of this study will not be shared with other investigators or industry partners for future research purposes." This is a pilot study and only aggregated data may be shared.
Related trials for Breast Cancer Survivor
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruitingPhase 2
A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors
Breast Cancer, Hyposexual Desire Disorder
Active, not recruitingObservational study
A Study of Attention and Memory Processes in Breast Cancer Survivors
Breast Cancer Survivors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorothy Sears, PhD principal investigator
Arizona State University
Sarah James, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Nightly Fasting and Health Education Videos in people with Breast Cancer Survivor and Cancer Related Cognitive Difficulties, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jen Project Coordinator (602-496-8248, restorestudy@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.