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 — BEHAVIORALParticipants 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 controlParticipants assigned to standard care will follow the recommendations by American Association for Cancer Research and the American Cancer Society.
- Experimental: 8-h TREParticipants 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
- Kelsey Gabel, RD, PhD312-413-8911
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | |
| University of Illinois Chicago | Chicago | Illinois | 60612 |
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