Intermittent Fasting for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
About this trial
This is an interventional supportive care trial for Anatomic Stage I Breast Cancer AJCC v8
Eligibility Criteria
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 at time of enrollment
Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma
- Multifocal or contralateral ductal carcinoma in situ (DCIS) or invasive breast cancers are allowed if the breast cancers meet the same eligibility criteria for ER/PR and HER2
- Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy
- Tumor status must be HER2 negative per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (determined by local testing)
- ER and PR expression must be < 10% cells positive by immunohistochemestry (IHC) test
- Patients must have clinical stage I-III (utilizing tumor, node, metastasis [TNM] criterion) at diagnosis
- Clinical T size must be >= 1.5 cm
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
* Acceptable regimen includes doxorubicin and cytoxan followed by paclitaxel (ACT; regimen can be standard or dose dense). Carboplatin cannot be added to the neoadjuvant chemotherapy regimen
- Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician
- 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
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
- Use of carboplatin in the neoadjuvant chemotherapy regimen
- 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 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 and behavioral lifestyle coaching in English
- Patients that are > 2 weeks into starting neoadjuvant chemotherapy regimen
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Arms of the Study
Arm 1
Experimental
Treatment (Intermittent Fasting)
Patients undergo intermittent fasting involving 14 hours of fasting and 10 hours of eating for approximately 4 months while undergoing standard of care neoadjuvant chemotherapy.