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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
55
Undergo TRE
Receive standard of care neoadjuvant chemotherapy
Undergo blood sample collection
Ancillary studies
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, United States
RECRUITINGSidney Kimmel Cancer Center Washington Township, , NJ USA
Sewell, New Jersey, United States
RECRUITINGThomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGJefferson Torresdale Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGAsplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
RECRUITINGProportion of patients who can adhere to time restricted eating (TRE) >= 70% of days
The proportion of patients that adhere to TRE will be estimated with the corresponding exact binomial 90% confidence interval.
Time frame: While undergoing neoadjuvant chemotherapy
Pathologic complete response (pCR) rate
Will be estimated with corresponding the exact binomial 90% confidence intervals.
Time frame: Up to 4 months
Percent of patients who maintain or have a reduced body mass index and waist circumference
Will be estimated with corresponding the exact binomial 90% confidence intervals.
Time frame: Up to 4 months
Percent of patients who develop grade 3 or 4 toxicities
Will be assessed using Common Terminology Criteria for Adverse Event (CTCAE) version (v) 5.0.
Time frame: Up to 4 months
Social determinants of health
Will be summarized descriptively for the entire study population and separately by the treatment received.
Time frame: Up to 4 months
pCR rate among Non-Hispanic White patients
Will be tabulated estimated with corresponding the exact binomial 90% confidence intervals for entire study population and separately by the treatment received.
Time frame: Up to 4 months
Acceptability, adherence, and engagement of TRE among African American versus Non-Hispanic White breast cancer patients
Time frame: Up to 4 months
Incidence of adverse events
Will assess percent of patients with CTCAE v5.0 grade 3 or 4 toxicities differs among African American versus non-Hispanic White breast cancer patients.
Time frame: Up to 4 months
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