Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotherapl… (NCT07387445) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.
United States40 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range25 Years – 99 Years
SexFEMALE
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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, che…