Could a 14-Hour fast ease breast cancer treatment side effects?
NCT ID NCT06106477
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial tests whether a six-month intermittent fasting plan—fasting for about 14 hours each night and eating within a 10-hour daytime window—is something women with early-stage, hormone-positive breast cancer can stick to while on hormone therapy. The goal is to see if this eating pattern can improve health-related quality of life and reduce inflammation. The study involves 20 women with stage I-III HR+/HER2- breast cancer and focuses on how feasible and acceptable the fasting schedule is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intermittent fasting (a daily eating pattern with a 14-hour overnight fast and a 10-hour eating window)
- What this could lead to
- If this approach proves feasible, it could offer a simple, drug-free way to ease side effects and improve well-being for women on hormone therapy for early breast cancer.
- What could go wrong
- This is a small feasibility study, not a proof of effectiveness. Results may not apply to all patients, and sticking to the fasting schedule for six months may be challenging for some.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. 7. Subjects who received neoadjuvant endocrine therapy are eligible only after completion of their definitive surgery (i.e., when ready to start adjuvant endocrine therapy) and treating provider ensures complete closure and healing of surgical incisions. 8. Subjects who had adjuvant systemic chemotherapy within two to four weeks prior to starting the IF intervention are eligible if they have recovered from acute effects of prior therapy to near baseline as determined by the treating physician. 9. Subjects on a targeted therapy, such as cyclin-dependent kinase (CDK) 4/6 inhibitor, or selective estrogen receptor degrader (SERD), or other clinical trial participants in the adjuvant setting are eligible at the discretion of the treating physician. 10. Subject co-administered with any prescriptions that may cause dizziness, hypoglycemia, or hypotension need to be evaluated and deemed eligible by the treating physician. 11. Adequate hepatic, renal function and adequate bone marrow reserve as determined by the treating physician: 1. aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × institutional upper limit. 2. Total bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with Gilbert's syndrome who may be included if their total bilirubin is ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN. 3. alkaline phosphatase (ALP) ≤ 2.5 × institutional upper limit with exception that ALP of \< 5 × ULN is acceptable in patients with elevated with ALP due to bone metastases (in the absence of liver metastases). 4. Serum creatinine \<1.5 × ULN. 5. Absolute neutrophil count (ANC) ≥1000/µL. 6. Subjects with lymphopenia are eligible at the discretion of the treating provider. i. Hemoglobin (Hb) ≥ 8g/dL. ii. Platelet count ≥ 100,000/µL. 12. Premenopausal woman: 1. Premenopausal is defined as someone who has had menses at any time in the last 12 months. For premenopausal women who are eligible for this trial, the treating physician may choose to monitor ovarian function with laboratory tests e.g., follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol as clinically indicated to assess their menopausal status. 2. Subjects must agree not to conceive throughout the study and must use accepted methods of contraception. 3. Women of childbearing potential must have a negative pregnancy test within seven days of registration and or seven to 10 days prior to starting study treatment. 13. Subjects who have an atypical sleep-wake schedule or different eating schedules are eligible at the discretion of the study investigators and dietitians as long as they agree to nightly fasting. 14. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 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). 9. History of heavy alcohol use as determined by the treating physician. 10. History of liver disease (cirrhosis, active hepatitis) or chronic renal disease. 11. Untreated or active infections such as hepatitis, human immunodeficiency virus (HIV), chronic unhealed infections. 12. Clinically significant illness or systemic disease as determined by the treating physician. 13. Recent hospitalization for a major illness, as determined by the treating physicians, within one month of enrollment. 14. Subject who is pregnant or breastfeeding. Subjects who become pregnant while on the study will be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Froedtert Hospital & the Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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