Finding studies
Finding studies
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Site Public Contact
CONTACT
Lead
Thomas Jefferson University
PRIMARY OBJECTIVE: I. To evaluate the proportion of patients that can adhere to TRE in patients with early stage breast cancer who receive neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. SECONDARY OBJECTIVES: I. To evaluate the pathologic complete response (pCR) rate of TRE in patients with early stage breast cancer who receive neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. II. To evaluate the effect of TRE in the weight management (prevention of weight gain), measured by BMI and waist circumference, in patients who are undergoing neoadjuvant chemotherapy. III. To evaluate the percent of patients who develop Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 3 or 4 toxicities IV. To evaluate the differences in the pCR rate among breast cancer patients within different race/ethnic groups, African American versus (vs.) Non-Hispanic White (AA vs NHW) and based on baseline social determinants of health when undergoing NCT. V. To evaluate if study intervention acceptability, adherence, and engagement differ by race (AA vs NHW) and based on baseline social determinants of health. VI. 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 OBJECTIVE: I. To monitor changes in the following inflammatory markers in patients undergoing neoadjuvant chemotherapy with TRE: fasting glucose, hemoglobin A1c, insulin, C-peptide, C-reactive protein (CRP), leptin, adiponectin, insulin-like growth factor 1 (IGF-1), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and free fatty acids and lipids. OUTLINE: Patients undergo TRE involving 16 hours of fasting and 8 hours of eating for 4 months while undergoing standard of care neoadjuvant chemotherapy. Patients also undergo blood sample collection on study. After completion of study treatment, patients are followed up for 6 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
