Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07387445
Status
Recruiting

Conditions

  • Breast Cancer
  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)
  • Breast Neoplasm Female

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Time restricted eating — BEHAVIORAL
    Participants assigned to this arm will follow the 8-h TRE protocol. Participants will consume food ad libitum (no calorie or food restrictions) during a self-selected 8-h eating window (beginning at 10:00 am, 11:00am, or 12:00 pm) and fasting for 16 hours daily. They will follow this same eating pattern for the length of the intervention. Calorie free drinks such as water, black coffee, and diet soda, are permitted during the fasting period. The eating window will allow for a typical breakfast/lunch/dinner eating pattern.

Study Details

This study is being done to better understand how time restricted eating (eating all food in an 8 hour window) can help a person receiving chemotherapy treatment for breast cancer, stages I-IV. The aim is to find out if time restricted is feasible and acceptable to individuals starting chemotherapy for breast cancer. We will test 3 different eating window options compared to a control group for 24 weeks.

Key Dates

Start date
Feb 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard Care control
    Participants assigned to standard care will follow the recommendations by American Association for Cancer Research and the American Cancer Society.
  • Experimental: 8-h TRE
    Participants assigned to this arm will follow the 8-h TRE protocol. Participants will consume food ad libitum (no calorie or food restrictions) during a self-selected 8-h eating window (beginning at 10:00 am, 11:00am, or 12:00 pm) and fasting for 16 hours daily. They will follow this same eating pattern for the length of the intervention. Calorie free drinks such as water, black coffee, and diet soda, are permitted during the fasting period. The eating window will allow for a typical breakfast/lunch/dinner eating pattern.

Primary Outcome Measure

Recruitment feasibility [ Time Frame: 24 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Robert H. Lurie Comprehensive Cancer CenterChicagoIllinois60611
Kelsey Gabel, RD PhD
(312) 413-8911
University of Illinois ChicagoChicagoIllinois60612
Kelsey Gabel, RD, PhD
312-413-8911

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