Time restricted eating for patients with HER2 negative breast cancer undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of time restricted eating (TRE) on patients with HER2 negative breast cancer who are starting neoadjuvant chemotherapy for stage I-III breast cancer. Participants will follow a 16:8 TRE schedule, fasting for 16 hours and eating during an 8-hour window, for 16 weeks while receiving treatment. The study aims to assess adherence to TRE, its impact on pathologic complete response rates, weight management, and the occurrence of severe toxicities. Additionally, it will explore differences in outcomes based on race and social determinants of health.

Why it matters

Who can join: the full rules

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

Where it's running

• Jefferson Cherry Hill Hospital
  Cherry Hill, New Jersey, United States Recruiting
• Sidney Kimmel Cancer Center Washington Township, , NJ USA
  Sewell, New Jersey, United States Recruiting
• Thomas Jefferson University Hospital
  Philadelphia, Pennsylvania, United States Recruiting
• Jefferson Torresdale Hospital
  Philadelphia, Pennsylvania, United States Recruiting
• Asplundh Cancer Pavilion
  Willow Grove, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Maysa Abu-Khalaf, MD, MBA — Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
• Study coordinator: Site Public Contact
• Email: ONCTrialNow@jefferson.edu
• Phone: 215-600-9151

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.