Actively Recruiting
Neoadjuvant Breast Cancer Time Restricted Eating
Led by Thomas Jefferson University · Updated on 2025-08-01
55
Participants Needed
1
Research Sites
248 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with HER2- negative breast cancer who will start neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Participants at baseline will have a body mass index (BMI) of (25-40) and engage in a TRE 16:8 schedule which includes 16 hours of fasting and 8 hours of eating. Patients will continue TRE for 16 weeks while receiving NCT. For patients who report at the time of the 2-3 week clinic visit that they are finding it challenging to adhere to the 16:8 TRE, instructions will be provided about alternative measures such as changing the time of the day they fast, dietary modifications and finally changing to a 14:10 schedule if other measures fail. For patients requiring NCT for longer than 16 weeks, they will be encouraged to continue TRE. Adherence calculation for the primary endpoint will include data for the first 16 weeks, and then monitored separately for any additional optional fasting beyond the first 16 weeks. Adherence to TRE will be self-reported by patients daily through electronic surveys through RedCap and approximately every 2-3 weeks (+/- 5 days) by the research team during their clinic visit.
CONDITIONS
Official Title
Neoadjuvant Breast Cancer Time Restricted Eating
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older and able to provide informed consent
- Body mass index (BMI) between 25 and 40 at enrollment
- ECOG performance status of 0 or 1
- Newly diagnosed with histologically confirmed primary invasive breast carcinoma
- Multifocal or contralateral breast cancers allowed if matching ER/PR and HER2 status
- Oligometastatic disease allowed if neoadjuvant chemotherapy is recommended
- Tumor must be HER2 negative as per local testing
- Clinical stage I to III breast cancer at diagnosis
- Tumor size at least 1.5 cm if no lymph node involvement; any size if lymph nodes involved
- Willing and able to receive at least 16 weeks of neoadjuvant chemotherapy
- Adequate organ and marrow function for chemotherapy
- Willing and able to participate in 16 weeks of time restricted eating
- Women of childbearing potential and sexually active males must use effective contraception or abstain during study and for 6 months after
- Have a personal email, internet-capable device, and ability/willingness to read and respond to emails daily during study
You will not qualify if you...
- Clinical T4 and/or N3 disease, including inflammatory breast cancer
- Prior treatment for current breast cancer diagnosis (surgery, chemotherapy, radiation, experimental therapy)
- Pregnant or breastfeeding women
- Expecting to conceive during study and for 6 months after last intervention
- Type 1 diabetes or type 2 diabetes treated with insulin
- History of eating disorder or use of weight loss medications
- Active smokers
- Working night shifts or rotating shift schedules
- Impaired decision-making capacity
- Non-English speakers
- More than 2 weeks into starting neoadjuvant chemotherapy regimen
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
M
Maysa Abu-Kalaf, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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