Clinical trial · Interventional
Prolonged Nightly Fasting in Breast Cancer Survivors
Pilot Study to Assess Prolonged Nightly Fasting in Breast Cancer Survivors
- 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)
This study is being done to examine whether fasting for 13 hours every night is feasible and if it can help breast cancer survivors lose weight and improve their health. * Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring. Recent research suggests that prolonged nighttime fasting (\>13 hours) may improve the risk of recurrence for breast cancer. * This study will examine if fasting for 13 hours per night is doable for participants and will also study what the effect of fasting is on quality of life, mood, fatigue, body size, and markers of health in the blood.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Recurrent | — | UNRESOLVED | — |
| Fasting | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fasting | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fasting
- description
- * Eligible participants will undergo baseline assessments prior to starting the intervention. * Baseline assessments include measurements of weight, height, quality of life, fatigue, mood, levels of physical activity, and blood markers. * Participants will fast for 13 hours nightly for 12 weeks. * Assessments will be repeated at the completion of the 12-week intervention.
- interventionNames
- Behavioral: Fasting
Primary outcomes (1)
- measure
- Percentage of Participants adhere to 13 hours of fasting
- timeFrame
- 12 weeks
- description
- Feasibility will be demonstrated if ≥60% of participants adhere to 13 hours of fasting nightly at least 70% of the nights during the intervention. Adherence will be assessed through patient-reported fasting logs.
Secondary outcomes (15)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have a documented history of histologically confirmed invasive breast cancer. * Participants with a history of stage I to III invasive breast cancer, and no current evidence of disease. * A history of bilateral breast cancer is allowed provided the patient is currently disease free, with stage I to III disease on both sides. * No evidence of distant metastatic disease or unresectable locally recurrent disease * All adjuvant or neoadjuvant cytotoxic chemotherapy, radiation, and surgery for breast cancer must have been completed at least 6 month prior to registration. Except: * Adjuvant hormonal therapy is permitted. Must have been on for a minimum of 1 month. * Adjuvant trastuzumab, pertuzumab, TDM1, or neratinib for Her2 positive breast cancer is permitted Age ≥18 years. * Participant must be female. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Distant metastatic breast cancer (Stage IV breast cancer) or unresectable locally recurrent disease * Participants with diabetes mellitus. * Participants with a pre-existing eating disorder (anorexia nervosa, bulimia) * Participants with a BMI\< 19kg/m2 or a weight loss of 5% in the last month or 10% in the last 3 months. * Participants using weight loss medications at the time of study enrollment. * Participants using oral steroids at the time of enrollment. * Participants who are receiving any other investigational agents. Participants with uncontrolled intercurrent illness. * Participants with psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because the effects of prolonged fasting on the fetus are not known.
References
Publications (1)
- RESULTO'Donnell E, Shapiro Y, Comander A, Isakoff S, Moy B, Spring L, Wander S, Kuter I, Shin J, Specht M, Kournioti C, Hu B, Sullivan C, Winters L, Horick N, Peppercorn J. Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). Breast Cancer Res Treat. 2022 Jun;193(3):579-587. doi: 10.1007/s10549-022-06594-4. Epub 2022 Apr 20. PMID 35441995