No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
25 – 99
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of Illinois at Chicago · Other
Who this trial is looking for
This trial is looking for women with early-stage breast cancer to explore if time-restricted eating can improve their treatment results. Participants will follow a specific eating schedule alongside a Mediterranean diet during chemotherapy.
Are You a Good Fit for This Trial?
Rules you outMetastatic breast cancerType 1 diabetesType 2 diabetesEating disorders
You may be able to join if
I am between 25 and 99 years old.
I have been diagnosed with Stage I-III breast cancer.
I have good organ function.
I can give written consent for this study.
I am not pregnant or breastfeeding.
I can follow study procedures for the entire trial.
You may not be able to join if
I have metastatic breast cancer.
I have type 1 or type 2 diabetes.
I have a BMI of 40 or higher or below 25.
I work the night shift.
I have a history of eating disorders.
I have gained or lost more than 4 kg in the last 3 months.
I have an active infection that needs treatment.
I have uncontrolled HIV/AIDS or active hepatitis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Breast cancer is the most common cancer in the United States however, little is known about how diet can affect cancer treatment. Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment rel…
Breast cancer is the most common cancer in the United States however, little is known about how diet can affect cancer treatment. Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, patient related outcomes, and limit treatment related weight gain and fat mass accretion.Time restricted eating combined with a mediterranean diet will also be feasible and improve cardiometabolic risk more than TRE alone or standard care.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 25-99 at time of consent
* ECOG 0 or 1
* Breast cancer to meet histologically confirmed Stage I-III.
* Demonstrates adequate organ function (absolutely neutrophil count ≥ 1,500/μL).
* All screening labs to be obtained within 30 days prior to registration.
* Able to provide…
Inclusion Criteria:
* Age 25-99 at time of consent
* ECOG 0 or 1
* Breast cancer to meet histologically confirmed Stage I-III.
* Demonstrates adequate organ function (absolutely neutrophil count ≥ 1,500/μL).
* All screening labs to be obtained within 30 days prior to registration.
* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
* Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
* As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Exclusion Criteria:
* Women with metastatic disease or type 1 or 2 diabetes
* Women with BMI ≥ 40kg/m2 and \< 25kg/m2
* Women who are pregnant. A negative serum or urine pregnancy test is required per institutional practice guidelines.
* Night shift workers
* Women with a history of eating disorders
* Enrolled participants with a significant weight loss or weight gain within 3 months of the study (weight gain or loss \>4kg)
* Active infection requiring systemic therapy
* Uncontrolled HIV/AIDS or active viral hepatitis
* Pregnant or nursing
* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
* Other major comorbidity, as determined by study PI
* Illicit drug use or excessive use of alcohol (i.e., \> 2 drinks/day)
* Currently participating in Weight Watcher's or another weight loss program
* Myocardial infarction
* Stroke
* Congestive heart failure
* Chronic hepatitis
* Cirrhosis
* Chronic pancreatitis
* History of solid organ transplantation
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