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Sponsor: Thomas Jefferson University
Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Invasive Breast Carcinoma
Interventions: Short-Term Fasting, Chemotherapy, Biospecimen Collection, Questionnaire Administration
Countries: United States
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Cherry Hill, New Jersey, United States
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- Philadelphia, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Willow Grove, Pennsylvania, United States