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
1 other identifier
interventional
30
1 country
1
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 (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Jan 2021
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2021
CompletedStudy Start
First participant enrolled
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedAugust 16, 2024
August 1, 2024
1.6 years
January 4, 2021
August 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of enrollment
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.
12 months
Rate of adherence to prolonged overnight fasting (POF) intervention goals
Feasibility will additionally be defined by participants achieving POF intervention goals on 70% of days by week 12.
12 weeks
Rate of adherence to exercise intervention goals
Feasibility will also be defined by at least 70% of participants achieving 120 minutes of aerobic exercise plus 2 strength training classes per week by week 12.
12 weeks
Secondary Outcomes (3)
Changes in metabolic biomarkers between baseline and week 12
12 weeks
Change in quality of life and patient-reported outcome measures between baseline and week 12
12 weeks
Differences in changes in metabolic biomarkers by treatment group (palbociclib vs palbocilib)
12 weeks
Study Arms (1)
Prolonged Nightly Fasting Plus Exercise
EXPERIMENTALParticipants 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.
Interventions
Restriction of consumption of calorie-containing food/drinks after 8pm
Personalized moderate-intensity, aerobic exercise and strength training
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosis of diabetes requiring medication
- Engaging in \>90 minutes of moderate or vigorous physical activity per week
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Ligibel, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 4, 2021
First Posted
January 14, 2021
Study Start
January 15, 2021
Primary Completion
August 30, 2022
Study Completion
July 31, 2024
Last Updated
August 16, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.