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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
University of Illinois Chicago
RECRUITING
Chicago
Contact Information
Primary
Kelsey Gabel, PhD
kdipma2@uic.edu
312-413-8911
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 40
Treatments
Experimental: Time restricted eating
Participants will eat all food within the same self selected 8 hour window daily.
No_intervention: Standard care
Current standard care is to eat enough calories and protein to maintain weight and lean mass.
Experimental: Med TRE
Participants will eat a mediterranean style diet within the same self selected 8 hour window daily.
Related Therapeutic Areas
Sponsors
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov