RecruitingNot ApplicableNCT05327608

Neoadjuvant Breast Cancer Time Restricted Eating

Time Restricted Eating for Patients With HER2- Negative Breast Cancer Receiving Neoadjuvant Chemotherapy


Sponsor

Thomas Jefferson University

Enrollment

55 participants

Start Date

Jul 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether time-restricted eating (limiting food consumption to a specific window of hours each day) during chemotherapy before breast cancer surgery can improve treatment outcomes in overweight or obese patients. **You may be eligible if...** - You are 18 or older with a BMI between 25 and 40 - You have been newly diagnosed with invasive breast cancer (stage I–III) - Your tumor is HER2-negative - Your doctor has recommended at least 16 weeks of chemotherapy before surgery - You have a personal email address and internet access **You may NOT be eligible if...** - Your cancer is stage T4 (including inflammatory breast cancer) - You have already received treatment for this breast cancer diagnosis - You are pregnant or breastfeeding - You have type 1 diabetes or type 2 diabetes treated with insulin - You have a history of an eating disorder - You work night shifts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTime Restricted Eating

Undergo intermittent fasting


Locations(1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

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NCT05327608


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