Time Restricted Eating for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery
Sponsored by Thomas Jefferson University
About this study
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 d…
Where this study is enrolling (5)
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Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey
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Sidney Kimmel Cancer Center Washington Township, , NJ USA
Sewell, New Jersey
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Asplundh Cancer Pavilion
Willow Grove, Pennsylvania
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Jefferson Torresdale Hospital
Philadelphia, Pennsylvania
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania
Who can participate
Inclusion criteria
- ✓Patient must be \>= 18 years of age at time of consent and must be able to understand and provide informed consent
- ✓BMI 25-40 at time of enrollment
- ✓Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- ✓Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma
- ✓\* Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy
- ✓Patients must have clinical stage I-III (utilizing tumor, node, metastasis \[TNM\] criterion) at diagnosis
- ✓Clinical T size must be \>= 1.5 cm if there is no radiographic or clinical evidence of axillary lymph node involvement. Any size tumor is allowed if axillary lymph nodes appear to be involved
- ✓Patient must be willing and able (have no contraindication) to receive recommended standard neoadjuvant therapy consisting of at least 16 weeks of planned neoadjuvant chemotherapy
- ✓Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician
- ✓Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks
- ✓Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 6 months after the last study intervention
- ✓Patient must have a personal email address, an internet-capable device, and the ability/ willingness to read and reply to email every day for the duration of the study
Exclusion criteria
- ✕Clinical T4 and/or N3 disease, including inflammatory breast cancer
- ✕Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy
- ✕Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 6 months after the last study intervention
- ✕Patients with type 1 diabetes, or type 2 diabetes treated with insulin
- ✕Patients with a history of eating disorder
- ✕Patients who work on a rotating shift schedule
- ✕Patients must not have impaired decision-making capacity
- ✕Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool
- ✕Patients that are \> 2 weeks into starting neoadjuvant chemotherapy regimen
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Trial data sourced from ClinicalTrials.gov.