Actively Recruiting
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer
Led by Medical College of Wisconsin · Updated on 2025-08-13
20
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Breast cancer patients 18 years or older willing to follow a 14-hour nighttime fasting and 10-hour daytime eating schedule.
- Confirmed diagnosis of estrogen receptor positive and HER2-negative localized breast cancer (stages I-III).
- Body mass index (BMI) of 25 or higher.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
- Willing to start intermittent fasting within three months of beginning adjuvant endocrine therapy or within 30 days of study enrollment.
- Fully recovered from chemotherapy side effects if previously treated.
- Completed definitive surgery and healing of surgical incisions if previously treated with neoadjuvant endocrine therapy.
- Recovered from recent adjuvant chemotherapy within two to four weeks prior to starting fasting.
- Eligible while on certain targeted therapies or other clinical trials, as approved by treating physician.
- Evaluated and approved if taking medications that may cause dizziness, low blood sugar, or low blood pressure.
- Adequate liver, kidney, and bone marrow function as determined by the treating physician.
- Premenopausal women must agree to use contraception and have a negative pregnancy test before starting.
- Eligible if they have atypical sleep or eating schedules but agree to nightly fasting.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Working late night shifts.
- Currently or recently (past year) on a fasting diet or weight loss agent like Ozempic.
- History of eating disorders such as anorexia or bulimia.
- Diagnosis of diabetes.
- Chronic dizziness or vertigo.
- Endocrine disorders causing blood sugar fluctuations.
- Poorly controlled neurological disorders.
- Poorly controlled heart disease including low blood pressure, heart failure, unstable angina, or arrhythmias.
- History of heavy alcohol use.
- Liver disease or chronic kidney disease.
- Untreated or active infections including hepatitis or HIV.
- Significant illness or systemic disease as judged by physician.
- Recent hospitalization for major illness within one month.
- Pregnancy or breastfeeding; becoming pregnant during the study leads to exclusion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here