Neoadjuvant Breast Cancer Time Restricted Eating

Launched by THOMAS JEFFERSON UNIVERSITY · Apr 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called time-restricted eating (TRE) for patients with certain types of breast cancer who are starting chemotherapy. In this trial, participants will follow a TRE schedule where they fast for 16 hours and eat during an 8-hour window each day for 16 weeks while receiving their chemotherapy treatment. The goal is to see if this eating pattern can help improve their health during treatment. If a participant finds it hard to stick to the 16:8 schedule, they will receive support and options to adjust their fasting time or reduce the fasting period to make it easier.

To be eligible for this study, participants must be at least 18 years old, have a body mass index (BMI) between 25 and 40, and have a recent diagnosis of specific types of breast cancer that are HER2 negative. They should also be able to commit to the study requirements, including daily reporting of their eating schedule through electronic surveys. This trial aims to help patients manage their eating habits alongside their cancer treatment, which could potentially lead to better outcomes.

Gender

ALL

Eligibility criteria

• • Inclusion Criterion
• Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
• • 1. Patient must be ≥ 18 years of age at time of consent and must be able to understand and provide informed consent.
• • 2. BMI 25-40 at time of enrollment.
• • 3. Patients must have an ECOG performance status of 0 or 1.
• • 4. Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma.
• • 1. Multifocal or contralateral DCIS or invasive breast cancers are allowed if the breast cancers meet the same eligibility criteria for ER/PR and HER2.
• • 2. Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy.
• • 5. Tumor status must be HER2 negative per ASCO/CAP guidelines (determined by local testing).
• • 6. Patients must have clinical stage I-III (utilizing TNM criterion) at diagnosis.
• • 7. Clinical T size must be ≥ 1.5cm 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.
• • 8. 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.
• • a. Acceptable regimen includes doxorubicin and cytoxan followed by a taxane The schedule will be determined by treating physician. Carboplatin and pembrolizumab can also be added to the neoadjuvant chemotherapy regimen if determined to be appropriate by treating physician.
• • 9. Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician.
• • 10. Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks
• • 11. 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.
• • 12. 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
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. Clinical T4 and/or N3 disease, including inflammatory breast cancer.
• • 2. Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy.
• • 3. 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.
• • 4. Patients with type 1 diabetes, or type 2 diabetes treated with insulin.
• • 5. Patients with a history of eating disorder or taking weight loss medications
• • 6. Patients who actively smoke
• • 7. Patients who work night shifts or on a rotating shift schedule.
• • 8. Patients must not have impaired decision-making capacity.
• • 9. Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool.
• • 10. Patients that are \>2 weeks into starting neoadjuvant chemotherapy regimen.