NCT05327608
Time Restricted Eating for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery
Recruiting · Not Applicable · Thomas Jefferson University · registry updated 2026-09-03
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This phase II trial studies whether time restricted eating (TRE) works to improve outcomes in patients with stage I-III breast cancer receiving chemotherapy before surgery (neoadjuvant) with a body mass index (BMI) 25-40. TRE has been shown to elicit similar metabolic changes as calorie restriction such as reduction in blood glucose levels, improved insulin sensitivity, and reduction of tumor cell growth. TRE may improve outcomes in patients with breast cancer.
Inclusion
- Patient must be \>= 18 years of age at time of consent and must be able to understand and provide informed consent
- BMI 25-40 at time of enrollment
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma
- \* Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy
- Patients must have clinical stage I-III (utilizing tumor, node, metastasis \[TNM\] criterion) at diagnosis
Exclusion
- Clinical T4 and/or N3 disease, including inflammatory breast cancer
- Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy
- Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 6 months after the last study intervention
- Patients with type 1 diabetes, or type 2 diabetes treated with insulin
- Patients with a history of eating disorder
- Patients who work on a rotating shift schedule