Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 12:29 PM
Study NCT ID:
NCT04708860
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2021-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Fasting & Exercise in Pts With HR+ MBC
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 kinase inhibitors in women with metastatic breast cancer (MBC).
Women who exercise regularly and who have lower levels of blood sugar and metabolic hormones like insulin have a lower risk of developing breast cancer. Some evidence also suggests that exercise and metabolism are related to cancer recurrence in women who are diagnosed with breast cancers that can be removed with surgery, but less is known about how exercise and metabolic factors are related to cancer progression in women whose cancer has advanced beyond the breast and underarm lymph nodes. This study is designed to look at the effects of exercise combined with prolonged nightly fasting (having a longer time between dinner and breakfast the next day), on blood sugar and hormones that control metabolism. This study looks to provide important information about whether making these kinds of changes is possible for women living with advanced breast cancer and will explore how making these changes effects blood sugar and hormone levels in women taking different kinds of treatments for advanced breast cancer.
The research study procedures include screening for eligibility, a baseline visit to collect information about diet and exercise habits, a baseline blood draw, participation in a 12-week diet and exercise program, and a follow up visit and blood collection at the end of the diet and exercise program.
Participants will be in this research study for up to 14-weeks, including the baseline and end of study visits to collect study measures.
It is expected that about 30 people will take part in this research study
Women who exercise regularly and who have lower levels of blood sugar and metabolic hormones like insulin have a lower risk of developing breast cancer. Some evidence also suggests that exercise and metabolism are related to cancer recurrence in women who are diagnosed with breast cancers that can be removed with surgery, but less is known about how exercise and metabolic factors are related to cancer progression in women whose cancer has advanced beyond the breast and underarm lymph nodes. This study is designed to look at the effects of exercise combined with prolonged nightly fasting (having a longer time between dinner and breakfast the next day), on blood sugar and hormones that control metabolism. This study looks to provide important information about whether making these kinds of changes is possible for women living with advanced breast cancer and will explore how making these changes effects blood sugar and hormone levels in women taking different kinds of treatments for advanced breast cancer.
The research study procedures include screening for eligibility, a baseline visit to collect information about diet and exercise habits, a baseline blood draw, participation in a 12-week diet and exercise program, and a follow up visit and blood collection at the end of the diet and exercise program.
Participants will be in this research study for up to 14-weeks, including the baseline and end of study visits to collect study measures.
It is expected that about 30 people will take part in this research study
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: