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Time-Restricted eating: a new way to ease chemo side effects?

NCT ID NCT07387445

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether time-restricted eating (eating all food within an 8-hour window each day) is feasible and helpful for women undergoing chemotherapy for early-stage breast cancer. Forty participants will either follow this eating pattern or a usual diet for 24 weeks. Researchers will track how well people stick to the diet, and measure quality of life, fatigue, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
time restricted eating (8-hour eating window, 16-hour fasting)
What this could lead to
If it works, this could offer a simple, drug-free way to reduce fatigue and improve quality of life during chemotherapy for breast cancer.
What could go wrong
This is a small, early feasibility study with only 40 participants, so results may not apply widely. It tests a behavioral change, not a drug, so benefits may be modest.

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

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

25 to 99 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 25-99 at time of consent * English language or Spanish language (based on availability of lab interpreters) * ECOG 0 or 1 * Breast cancer to meet histologically confirmed Stage I-III or Stage IV with Medical Oncology approval. * Demonstrates adequate organ function (absolute 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 type 1 or insulin dependent type 2 diabetes * Women with BMI \> 45kg/m2 and \< 18.5 kg/m2 * Women who are pregnant or nursing. A negative serum or urine pregnancy test is required per institutional practice guidelines. * 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) * Uncontrolled HIV/AIDS or active viral hepatitis * Any prior malignancy \<5 years, chemotherapy within the last year 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. * Breast cancer recurrence classified 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 within previous 3 months or excessive use of alcohol (i.e., \> 2 drinks/day) * Currently participating in Weight Watcher's or another weight loss program, including weight loss medication such as GLP-1 medications. * Myocardial infarction * Congestive heart failure * Chronic hepatitis * Cirrhosis * Chronic pancreatitis * History of solid organ transplantation

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Fasting Intermittent Fasting

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Robert H. Lurie Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60611, United States

  • University of Illinois Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

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