Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06106477
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-10-24
Brief Title:
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life A Feasibility Trial for Women With HRHER2- Early Breast Cancer
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life A Feasibility Trial for Women With HRHER2- Early Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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 single-arm study is designed to test the hypothesis that a six-month intermittent fasting IF intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant endocrine therapy AET
Detailed Description:
This is a single-arm pilot study n20 designed to evaluate whether a six-month intermittent fasting IF intervention defined as a daily recurring fourteen-hour nightly fasting period is feasible to adhere to and feasible to determine health outcomes in breast cancer patients with a body mass index BMI of 25 and who are scheduled to start adjuvant endocrine therapy AET after definitive therapy
Subjects with hormone receptor positive HER2-negative breast cancer will be enrolled into this study Data on study feasibility quality of life QOL and anthropometric measurements and biomarkers will be collected and analyzed After the study is completed the investigators may also perform a post-hoc analysis on subjects who received adjuvant chemotherapy in combination with AET vs AET alone
Subjects with hormone receptor positive HER2-negative breast cancer will be enrolled into this study Data on study feasibility quality of life QOL and anthropometric measurements and biomarkers will be collected and analyzed After the study is completed the investigators may also perform a post-hoc analysis on subjects who received adjuvant chemotherapy in combination with AET vs AET alone
Study Oversight
Has Oversight DMC:
None
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?:
None