Clinical trial · Interventional
Feasibility of Fasting & Exercise in Pts With HR+ MBC
Pilot Study of the Impact of a Combined Intermittent Fasting and Exercise Intervention on Metabolic Markers in Patients With Advanced, Hormone Receptor Positive Breast Cancer
NCT04708860CI-TRIAL-00079881completedN/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)
This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.
Conditions
Conditions (2)
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 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
| Prolonged Nightly Fasting | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prolonged Nightly Fasting Plus Exercise
- description
- Participants will be grouped into two cohorts determined by whether they receive palbociclib or alpelisib as part of their breast cancer treatment and then receive a 12 week prolonged nightly fasting plus exercise program consisting of: * Prolonged overnight fasting: Not consume any calorie-containing food/drinks after 8pm, waiting a minimum of 13 hours after their last meal of the day before eating the next day, target goal of fasting at least 6 days a week, daily record of first and last meals * Exercise Program: Coach provided at-home, personalized exercise regimen with target goal of 120 minutes of moderate-intensity aerobic activity each week as well as two 30-45-minute virtual strength training classes per week, receive fitbit for exercise and heart rate monitoring, weekly telephone-based support sessions with coach.
- interventionNames
- Behavioral: Prolonged Nightly Fasting
- Behavioral: Exercise
Primary outcomes (3)
- measure
- Rate of enrollment
- timeFrame
- 12 months
- description
- The primary objective is to evaluate the feasibility of the intervention. Feasibility will be defined by the rate of enrollment and the intervention will be considered feasible if at least 80% of planned participants are enrolled within 12 months of study activation.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of ER and/or PR+ metastatic or locally unresectable breast cancer * Postmenopausal (including concurrent use of ovarian suppression) * Initiating endocrine therapy in combination with: * Cohort 1: alpelisib * Cohort 2: palbociclib * Self-reported ability to walk two blocks * \> 18 years of age * Approval from treating oncologist, confirmed via email or in writing * Ability to read and understand English Exclusion Criteria: * Diagnosis of diabetes requiring medication * Engaging in \>90 minutes of moderate or vigorous physical activity per week
References
Publications (0)
Data not yet available
No reference posted for this study.