Clinical trial NCT06938555: The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors
Official title: The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Survivor
Cancer Related Cognitive Difficulties
Sleep
Quality of Life
Keywords: breast cancer
breast cancer survivor
brain fog
prolonged nightly fasting
nationwide
remote
non-invasive
health education
sleep
quality of life
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2025-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition.
timeFrame: Baseline (T1) and 8-week end point (T2) data collection
measure: Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition.
timeFrame: Baseline (T1) and 8-week end point (T2) data collection
Secondary outcomes:
measure: Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.
timeFrame: Baseline (T1) and 8-week end point (T2) data collection
measure: Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.
timeFrame: Baseline (T1) and 8-week end point (T2) data collection
measure: Examine PNF-induced changes in quality of life as compared to the HED-Only Control condition.
timeFrame: Baseline (T1) and 8-week end point (T2) data collection.
Other outcomes:
measure: Exploratory Aim: Explore acceptability of the PNF intervention
timeFrame: 8-week end point (T2) data collection
measure: Exploratory Aim: Explore acceptability of the PNF intervention
timeFrame: 8-week end point (T2) data collection
measure: Exploratory Aim: Explore acceptability of the PNF intervention
timeFrame: 8-week end point (T2) data collection
measure: Covariate Measure: eating behaviors
timeFrame: Baseline (T1) and 8-week end point (T2) data collection.
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Dorothy Sears, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Sarah James, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: