Time Restricted Eating for Early-Stage Breast Cancer

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

Recruiting N/A Interventional Study
Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Invasive Breast Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
55 (estimated)
Sponsor
Thomas Jefferson University · Other
Who this trial is looking for

This trial is looking for adults with early-stage breast cancer who are starting chemotherapy. Taking part involves following a specific eating schedule for 16 weeks while undergoing treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have a body mass index (BMI) between 25 and 40.
  • I have been diagnosed with invasive breast cancer.
  • My cancer is at stage I-III.
  • I am willing to follow the eating schedule for 16 weeks.
  • I have good health to start chemotherapy.
  • I can communicate in English.
  • I have an email address and can check it daily.

You may not be able to join if

  • I have clinical T4 or N3 disease.
  • I have had any prior treatment for my current breast cancer.
  • I am pregnant or breastfeeding.
  • I have type 1 diabetes or type 2 diabetes treated with insulin.
  • I have a history of eating disorders.
  • I work on a rotating shift schedule.
  • I have impaired decision-making capacity.
  • I started my chemotherapy more than 2 weeks ago.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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…
Trial Locations
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Eligibility Criteria
INCLUSION CRITERIA: * Patient must be \>= 18 years of age at time of consent and must be able to understand and provide informed consent * BMI 25-40 at time of enrollment * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patient must have a recent diag…
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