Time Restricted Eating for HER2-Negative Breast Cancer
This study is looking at whether a special eating plan called Time Restricted Eating (TRE), also known as intermittent fasting, can be helpful for people with HER2-negative breast cancer (a type of breast cancer that doesn't have too much of a protein called HER2) who are starting chemotherapy before surgery (neoadjuvant chemotherapy). You would follow a 16:8 schedule, meaning you fast for 16 hours and eat during an 8-hour window each day, for 16 weeks. The main goal is to see how many people can stick to this eating plan at least 70% of the time while on chemotherapy. This study is for adults aged 18 or older with stage I-III breast cancer and a BMI between 25 and 40.
- Study design
- This is an interventional study, meaning participants will receive a specific intervention (Time Restricted Eating). It plans to enroll 55 participants.
- What's involved
- Participants will follow a 16:8 Time Restricted Eating schedule for 16 weeks while receiving neoadjuvant chemotherapy. There will be check-ins to help with adherence.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, adherence to Time Restricted Eating, is measured while undergoing neoadjuvant chemotherapy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Neoadjuvant Breast Cancer Time Restricted Eating
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Maysa Abu-Khalaf, MD, MBA · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Who to contact
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What this trial measures
- 1. Proportion of patients who can adhere to time restricted eating (TRE) >= 70% of daysWhile undergoing neoadjuvant chemotherapy
A patient's adherence will be measured as the percent (%) of days where a patient reports on the survey that they were able to complete at least 14 or more hours of fasting per 24 hours (each day) during 16 weeks (112 days) of neoadjuvant chemotherapy. A patient will be considered adherent to TRE if percent (%) of days where a patient reports on the survey that they were able to complete at least 14 or more hours of fasting per 24 hours (each day) during 16 weeks is 70% or higher. For patients who complete \< 16 weeks of chemotherapy from the date of starting TRE, adherence will be computed based on number of days of chemotherapy cycles received. If the proportion of days with confirmed TRE adherence is 70% or greater, then the patient is considered to have achieved overall TRE adherence.