Evaluating Time Restricted Eating During Neoadjuvant Chemotherapy in Early-Stage HER2-Negative Breast Cancer

What this Trial Is About

Researchers are evaluating an innovative approach called Time Restricted Eating TRE in patients diagnosed with early-stage breast cancer stage I-III who are starting neoadjuvant chemotherapy NCT. This phase II study focuses on patients with a body mass index BMI between 25 and 40. The primary goal is to determine how many patients can adhere to TRE during chemotherapy, while also studying effects on tumor response, weight management, treatment toxicity, and differences among racial groups. Participants will follow a TRE schedule of fasting for 16 hours and eating within an 8-hour window 168 for 16 weeks while receiving neoadjuvant chemotherapy. If patients find this schedule challenging by the 2-3 week clinic visit, they may receive guidance on adjusting fasting times, diet modifications, or switching to a 1410 fasting schedule. Those requiring chemotherapy beyond 16 weeks can continue TRE, but adherence beyond the initial period will be monitored separately. Throughout the study, participants will self-report adherence daily using electronic surveys, with additional check-ins every 2-3 weeks during clinic visits. Researchers will assess adherence rates, tumor response, changes in BMI and waist circumference, treatment-related toxicities, and inflammatory and metabolic markers in blood and tissue samples. The study includes monitoring over approximately four months, with ongoing assessment of patient engagement and safety during therapy.

Neoadjuvant Breast Cancer Time Restricted Eating