NCT07387445 Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.
| NCT ID | NCT07387445 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Chicago |
| Condition | Breast Cancer Early Stage Breast Cancer (Stage 1-3) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07387445 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 99 Years, studying Breast Cancer Early Stage Breast Cancer (Stage 1-3). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07387445 currently recruiting?
Yes, NCT07387445 is actively recruiting participants. Contact the research team at kdipma2@uic.edu for enrollment information.
Where is the NCT07387445 trial being conducted?
This trial is being conducted at Chicago, United States, Chicago, United States.
Who is sponsoring the NCT07387445 clinical trial?
NCT07387445 is sponsored by University of Illinois at Chicago. The trial plans to enroll 40 participants.
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