Neoadjuvant Breast Cancer Time Restricted Eating
Recruiting now · Not applicable
Conditions studied: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Ductal Carcinoma in Situ, HER2 Negative Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05327608
- Run by
- Thomas Jefferson University
- People needed
- 55
- Starts
- 2022-07-28
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2025-08-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 or taking weight loss medications
- Patients who actively smoke
- Patients who work night shifts or 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 is running
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.