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

Not Applicable

Recruiting

• Conditions: Breast Cancer Survivor; Cancer Related Cognitive Difficulties; Sleep; Quality of Life

• Registration Number: NCT06938555
• Lead Sponsor: Arizona State University

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.

Study Timeline

• Study Start: 2025-03-18
• Study First Submitted: 2025-03-28
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Primary Completion: 2026-03-18
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	The Montreal Cognitive Assessment (T-MoCA) will be used to assess objective cognitive assessment using a scale of 0-22

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States