RECRUITING

Time Restricted Eating During Chemotherapy for Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Breast cancer is the most common cancer in the United States however, little is known about how diet can affect cancer treatment. Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, patient related outcomes, and limit treatment related weight gain and fat mass accretion.Time restricted eating combined with a mediterranean diet will also be feasible and improve cardiometabolic risk more than TRE alone or standard care.

Official Title

The Safety and Efficacy of Time Restricted Eating Alone or Combined the Mediterranean Diet During Chemotherapy for Breast Cancer

Quick Facts

Study Start:2022-08-01

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05259410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 99 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 25-99 at time of consent * ECOG 0 or 1 * Breast cancer to meet histologically confirmed Stage I-III. * Demonstrates adequate organ function (absolutely neutrophil count ≥ 1,500/μL). * All screening labs to be obtained within 30 days prior to registration. * Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. * Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines. * As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.	* Women with metastatic disease or type 1 or 2 diabetes * Women with BMI ≥ 40kg/m2 and \< 25kg/m2 * Women who are pregnant. A negative serum or urine pregnancy test is required per institutional practice guidelines. * Night shift workers * Women with a history of eating disorders * Enrolled participants with a significant weight loss or weight gain within 3 months of the study (weight gain or loss \>4kg) * Active infection requiring systemic therapy * Uncontrolled HIV/AIDS or active viral hepatitis * Pregnant or nursing * Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist. * Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial. * Other major comorbidity, as determined by study PI * Illicit drug use or excessive use of alcohol (i.e., \> 2 drinks/day) * Currently participating in Weight Watcher's or another weight loss program * Myocardial infarction * Stroke * Congestive heart failure * Chronic hepatitis * Cirrhosis * Chronic pancreatitis * History of solid organ transplantation

Inclusion Criteria

Exclusion Criteria

* Age 25-99 at time of consent
* ECOG 0 or 1
* Breast cancer to meet histologically confirmed Stage I-III.
* Demonstrates adequate organ function (absolutely neutrophil count ≥ 1,500/μL).
* All screening labs to be obtained within 30 days prior to registration.
* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
* Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
* As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

* Women with metastatic disease or type 1 or 2 diabetes
* Women with BMI ≥ 40kg/m2 and \< 25kg/m2
* Women who are pregnant. A negative serum or urine pregnancy test is required per institutional practice guidelines.
* Night shift workers
* Women with a history of eating disorders
* Enrolled participants with a significant weight loss or weight gain within 3 months of the study (weight gain or loss \>4kg)
* Active infection requiring systemic therapy
* Uncontrolled HIV/AIDS or active viral hepatitis
* Pregnant or nursing
* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
* Other major comorbidity, as determined by study PI
* Illicit drug use or excessive use of alcohol (i.e., \> 2 drinks/day)
* Currently participating in Weight Watcher's or another weight loss program
* Myocardial infarction
* Stroke
* Congestive heart failure
* Chronic hepatitis
* Cirrhosis
* Chronic pancreatitis
* History of solid organ transplantation

Contacts and Locations

Study Contact

Kelsey Gabel, PhD

CONTACT

312-413-8911

kdipma2@uic.edu

Principal Investigator

Kelsey Gabel, MS, RD, PhD

PRINCIPAL_INVESTIGATOR

UIC

Study Locations (Sites)

University of Illinois Chicago

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Kelsey Gabel, MS, RD, PhD, PRINCIPAL_INVESTIGATOR, UIC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2022-08-01

Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer Female