Recruiting

Time Restricted Eating

Sponsor:

Thomas Jefferson University

Code:

NCT05327608

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Short-Term Fasting

Chemotherapy

Biospecimen Collection

Questionnaire Administration

Study Details

Brief summary:

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.

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

Study ID

NCT05327608

Start date

Jul 28, 2022

Status verified date

Aug, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment (TRE)

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.

Interventions

Short-Term Fasting

Undergo TRE

Chemotherapy

Receive standard of care neoadjuvant chemotherapy

Biospecimen Collection

Undergo blood sample collection

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Proportion of patients who can adhere to time restricted eating (TRE) >= 70% of days [ Time Frame: While undergoing neoadjuvant chemotherapy ]

Central Contacts and Locations

Central contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Locations

Jefferson Cherry Hill Hospital

Recruiting

Cherry Hill, New Jersey, United States, 08002

Contacts

Maysa Abu-Khalaf, MD

215-955-8874

Sidney Kimmel Cancer Center Washington Township, , NJ USA

Recruiting

Sewell, New Jersey, United States, 08080

Contacts

Maysa Abu-Khalaf, MD

215-955-8874

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Maysa Abu-Khalaf, MD

215-955-8874ONCTrialNow@jefferson.edu

Principal Investigator:

Maysa Abu-Khalaf, MD

Jefferson Torresdale Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Contacts

Maysa Abu-Khalaf, MD

215-955-8874

Asplundh Cancer Pavilion

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

Maysa Abu-Khalaf, MD

215-955-8874

More Information

Sponsor

Thomas Jefferson University

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-09-03.