Time Restricted Eating for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery
Start Date
7/28/2022
Completion Date
5/1/2027
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Short-Term Fasting
Chemotherapy
Biospecimen Collection
Questionnaire Administration
Conditions
Locations
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey 08002
United States
Sidney Kimmel Cancer Center Washington Township, , NJ USA
Sewell, New Jersey 08080
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania 19114
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United States