RecruitingBreast Cancer
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
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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).
Sponsor: Medical College of Wisconsin
You may qualify if…
- ✓ 1. Breast cancer patients ≥ 18 years old who are willing to consent to an approximately 14-hour nighttime fasting period and an approximately 10-hour daytime eating period.
- ✓ 2. Histologically and/or cytologically confirmed diagnosis of estrogen receptor (ER) positive (ER+) and human epidermal growth factor receptor (HER) 2 negative (HER2-) localized breast cancer (stages I-III).
- ✓ 1. Progesterone receptor positive or negative patients are allowed.
- ✓ 2. Hormone receptor positivity is defined as ER positivity in at least 1% cells by immunohistochemistry (IHC). HER 2-negative breast cancer is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization fluorescence in situ hybridisation (FISH), chromogenic in situ hybridization (CISH), or silver-enhanced in situ hybridization (SISH) test is required.
- ✓ 3. Body mass index (BMI) ≥ 25.
- ✓ 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- ✓ 5. Subject must be willing to start the intermittent fasting (IF) intervention within three months of starting adjuvant endocrine therapy (AET), or at the discretion of the treating providers, and within 30 days of study enrollment.
- ✓ 6. Subjects who received neoadjuvant or adjuvant chemotherapy must have recovered completely from chemotherapy-related side effects such as nausea/emesis as determined by the treating providers.
You may not qualify if…
- ✕ 1. Subject who works late night shifts.
- ✕ 2. Subject that was or currently on a fasting diet (e.g., Keto diets), intervention, or an agent (e.g., Ozempic) for the explicit purpose of inducing weight loss in the past one year.
- ✕ 3. Subject with a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa).
- ✕ 4. Presence of diabetes.
- ✕ 5. Presence of chronic dizziness or vertigo.
- ✕ 6. Presence of endocrine disorders prone to fluctuations in blood sugar (e.g., multiple neuroendocrine disorders, adrenal disorders, chronic hypoglycemia).
- ✕ 7. Poorly controlled neurological disorders as determined by the treating physician (e.g., epilepsy, Parkinson's disease, myasthenia gravis, syncope, pre-syncopal episodes).
- ✕ 8. Poorly controlled co-existing cardiac disease as determined by the treating physician, such as chronic hypotension, symptomatic congestive heart failure (New York Heart Association III-IV), unstable angina, arrythmia (e.g., atrial fibrillation, bradycardia, tachycardia).
Where it's recruiting
Wisconsin
Milwaukee
Source: ClinicalTrials.gov · NCT06106477 · last updated 2025-08-13