Status:
COMPLETED
Feasibility of Fasting & Exercise in Pts With HR+ MBC
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Breast Cancer
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This is single-arm feasibility pilot study exploring whether a combined prolonged nightly fasting (POF) and exercise program could impact hyperglycemia and other adverse metabolic consequences of PI3 ...
Eligibility Criteria
Inclusion
- 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
- Diagnosis of diabetes requiring medication
- Engaging in \>90 minutes of moderate or vigorous physical activity per week
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04708860
Start Date
January 15 2021
End Date
July 31 2024
Last Update
August 16 2024
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215