Clinical trial · Interventional
The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors
The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)
NCT06938555CI-TRIAL-00110082RESTORErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivor | — | UNRESOLVED | — |
| Cancer Related Cognitive Difficulties | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Sleep | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Health Education Videos | Behavioral | — | UNRESOLVED |
| Prolonged Nightly Fasting | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prolonged Nightly Fasting and Health Education Videos
- description
- Participants in the Prolonge + HED condition will receive both the Prolonged Nightly Fasting and the Health Education Video interventions.
- interventionNames
- Behavioral: Prolonged Nightly Fasting
- Behavioral: Health Education Videos
- type
- ACTIVE_COMPARATOR
- label
- Health Education Videos Only
- description
- 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.
- interventionNames
- Behavioral: Health Education Videos
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.