NCT04708860Completed
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
Source: ClinicalTrials.gov · Last updated 16 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 4 Jan 2021
- Start date
- 15 Jan 2021
- Primary completion date
- 30 Aug 2022
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04708860
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 15 Jan 2021 to the primary completion date, 30 Aug 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of diabetes requiring medication
Other
- Engaging in \>90 minutes of moderate or vigorous physical activity per week
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.