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Time Restricted Eating for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery

Time Restricted Eating for Patients With Early Stage Breast Cancer Receiving Neoadjuvant Chemotherapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 months, 6 months
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "OUTLINE: Patients undergo TRE involving 16 hours of fasting and 8 hours of eating for 4 months while undergoing standard of care neoadjuvant chemotherapy."
  • "Patients also undergo blood sample collection on study."
  • "After completion of study treatment, patients are followed up for 6 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether time-restricted eating—eating only during set hours—can improve results from breast cancer treatment. It is for adults with stage I–III breast cancer who are getting chemotherapy before surgery and have a body mass index (BMI) of 25–40.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, able to understand the study and agree to join.
  • BMI of 25–40. BMI is a measure of weight compared with height.
  • Fully active or able to do light work, even if hard physical activity is limited.
  • Recently diagnosed with invasive breast cancer confirmed by a tissue test, at stage I–III. Limited spread to distant sites is allowed if the doctor recommends standard chemotherapy before surgery.
  • Tumor is at least 1.5 cm if there are no signs of cancer in underarm lymph nodes. Any tumor size is allowed if those nodes appear affected.
  • Able and willing to receive at least 16 weeks of planned chemotherapy before surgery and follow time-restricted eating for 16 weeks. The doctor must find organ and bone marrow function safe for chemotherapy.
  • Women who could become pregnant and sexually active men must use effective birth control or avoid sex during the study and for 6 months after the last study treatment.
  • Have a personal email address and a device with internet access, and be able and willing to read and answer email daily.

Who can't join

  • Cancer classified as T4 or N3, meaning certain advanced stages of tumor growth or lymph node spread, including inflammatory breast cancer.
  • Any past treatment for the current breast cancer, including surgery, chemotherapy, radiation, or experimental treatment; or more than 2 weeks into chemotherapy before surgery.
  • Pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last study treatment.
  • Type 1 diabetes, or type 2 diabetes treated with insulin.
  • A history of an eating disorder.
  • Work on a rotating shift schedule.
  • Limited ability to make decisions.
  • Do not speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 25-40 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

Study sites (5)

NJ

PA