Trials / Recruiting

RecruitingNCT05327608

Neoadjuvant Breast Cancer Time Restricted Eating

Time Restricted Eating for Patients With HER2- Negative Breast Cancer Receiving Neoadjuvant Chemotherapy

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 55 (estimated)

Sponsor: Thomas Jefferson University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with HER2- negative breast cancer who will start neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Participants at baseline will have a body mass index (BMI) of (25-40) and engage in a TRE 16:8 schedule which includes 16 hours of fasting and 8 hours of eating. Patients will continue TRE for 16 weeks while receiving NCT. For patients who report at the time of the 2-3 week clinic visit that they are finding it challenging to adhere to the 16:8 TRE, instructions will be provided about alternative measures such as changing the time of the day they fast, dietary modifications and finally changing to a 14:10 schedule if other measures fail. For patients requiring NCT for longer than 16 weeks, they will be encouraged to continue TRE. Adherence calculation for the primary endpoint will include data for the first 16 weeks, and then monitored separately for any additional optional fasting beyond the first 16 weeks. Adherence to TRE will be self-reported by patients daily through electronic surveys through RedCap and approximately every 2-3 weeks (+/- 5 days) by the research team during their clinic visit.

Detailed description

Primary objective: 1\. To evaluate the proportion of patients that can adhere to Time Restricted Eating (TRE) in patients with HER2 negative breast cancer who receive neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Secondary objectives: 1. To evaluate the pathologic complete response (pCR) rate of TRE in patients with HER2 negative breast cancer who receive NCT for a new diagnosis of stage I-III breast cancer 2. To evaluate the effect of TRE on weight management (prevention of weight gain), measured by BMI and waist circumference, in patients who are undergoing NCT. 3. To evaluate the percent of patients who develop CTCAE version 5.0 grade 3 or 4 toxicities 4. To evaluate the differences in the pCR rate among breast cancer patients within different race/ethnic groups, African American vs. Non-Hispanic White (AA vs NHW), and based on baseline social determinants of health when undergoing NCT 5. To evaluate if study intervention acceptability, adherence, and engagement differ by race (AA vs NHW) and based on baseline social determinants of health. 6. To evaluate if percent of patients with CTCAE version 5.0 grade 3 or 4 toxicities differ by race (AA vs NHW) and based on baseline social determinants of health. Exploratory objectives: 1. To monitor changes in the following inflammatory markers in patients undergoing neoadjuvant chemotherapy with TRE: fasting glucose, hemoglobin A1c, insulin, C-peptide, CRP, leptin, adiponectin,IGF-1, IL-6, TNF-α, and free fatty acids and lipids 2. To measure changes in markers involved in metabolic and lipogenic signaling pathways, immune modulation, and autophagy in adipocytes, tumor cells, and surrounding immune cells by Reverse-Phase Protein microarrays (RPPA) analysis. For this analysis we will use on tissue from baseline diagnostic tissue biopsies and post TRE plus neoadjuvant chemotherapy surgical tissue resection, when available

Conditions

Interventions

Type	Name	Description
OTHER	Time Restricted Eating	Undergo intermittent fasting

Timeline

Start date: 2022-07-28
Primary completion: 2027-05-01
Completion: 2027-05-01
First posted: 2022-04-14
Last updated: 2025-08-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05327608. Inclusion in this directory is not an endorsement.