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Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.

Time Restricted Eating During Chemotherapy for Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 99 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "We will test 3 different eating window options compared to a control group for 24 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether eating all food within an 8-hour window is practical and acceptable for people starting chemotherapy for stage I–IV breast cancer. It compares 3 eating-window options with a control group over 24 weeks.

This study is being done to better understand how time restricted eating (eating all food in an 8 hour window) can help a person receiving chemotherapy treatment for breast cancer, stages I-IV. The aim is to find out if time restricted is feasible and acceptable to individuals starting chemotherapy for breast cancer. We will test 3 different eating window options compared to a control group for 24 weeks.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 25–99 years old when you agree to join.
  • Speak English or Spanish; Spanish depends on interpreter availability.
  • Be fully active or able to do light work despite limits on hard physical activity (ECOG score 0 or 1).
  • Have stage I–III breast cancer confirmed by a tissue test, or stage IV breast cancer with approval from the cancer doctor.
  • Have adequate organ function, including at least 1,500 neutrophils (infection-fighting white blood cells) per microliter of blood. Screening blood tests must be done within 30 days before signing up.
  • Give written consent to join and permission to share personal health information.
  • If able to become pregnant, not be pregnant or breastfeeding and have a negative pregnancy test.
  • Be able to understand and follow study steps for the whole study, as judged by the study team.

Who can't join

  • Type 1 diabetes or type 2 diabetes that needs insulin. The BMI (weight compared with height) rule says “above 45 and below 18.5”; ask the study team to clarify.
  • Pregnancy, breastfeeding, shift work, or a history of eating disorders.
  • Gaining or losing more than 4 kg (about 9 pounds) within 3 months, or using a weight-loss program or medicine, including GLP-1 medicines.
  • Uncontrolled HIV/AIDS; active viral or long-term hepatitis (liver inflammation); cirrhosis (liver scarring); or long-term pancreas inflammation.
  • Cancer within the past 5 years, chemotherapy within the past year, another current cancer that could affect study safety or results, or breast cancer that has returned.
  • A heart attack, heart failure, or a history of an organ transplant.
  • A mental or medical condition that prevents consent or participation, or another major illness identified by the study leader.
  • Illegal drug use within the past 3 months or more than 2 alcoholic drinks a day.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

IL