Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: … (NCT06106477) | Clinical Trial Compass
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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
United States20 participantsStarted 2024-07-19
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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).
. Progesterone receptor positive or negative patients are allowed.
. 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.
. Body mass index (BMI) ≥ 25.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subject adherence to the intermittent fasting schedule.
Timeframe: Six months
Trial details
NCT IDNCT06106477
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-07-15
Contact for this trial
Medical College of Wisconsin Cancer Center Clinical Trials Office
. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
. 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.
. 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.
Exclusion criteria
. Subject who works late night shifts.
. 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.
. Subject with a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa).
. Presence of diabetes.
. Presence of chronic dizziness or vertigo.
. Presence of endocrine disorders prone to fluctuations in blood sugar (e.g., multiple neuroendocrine disorders, adrenal disorders, chronic hypoglycemia).
. Poorly controlled neurological disorders as determined by the treating physician (e.g., epilepsy, Parkinson's disease, myasthenia gravis, syncope, pre-syncopal episodes).
. 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).