RecruitingNot ApplicableNCT05327608

Time Restricted Eating for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery

Time Restricted Eating for Patients With Early Stage Breast Cancer Receiving Neoadjuvant Chemotherapy


Sponsor

Thomas Jefferson University

Enrollment

55 participants

Start Date

Jul 28, 2022

Study Type

INTERVENTIONAL

Conditions

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.


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

OTHERShort-Term Fasting

Undergo TRE

DRUGChemotherapy

Receive standard of care neoadjuvant chemotherapy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

OTHERQuestionnaire Administration

Ancillary studies


Locations(5)

Jefferson Cherry Hill Hospital

Cherry Hill, New Jersey, United States

Sidney Kimmel Cancer Center Washington Township, , NJ USA

Sewell, New Jersey, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

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NCT05327608


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