Neoadjuvant Breast Cancer Time Restricted Eating

Recruiting Phase 2 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
55 (estimated)
Sponsor
Thomas Jefferson University · Other
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About This Trial
A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with early-stage 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. Patie…
Trial Locations
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Eligibility Criteria
Inclusion Criterion Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: 1. Patient must be ≥ 18 years of age at time of consent and must be able to understand and provide informed consent. 2. BMI 25-40 at time of enrollment. 3. Patient…
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